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Trial record 27 of 158 for:    Diseases | ( Map: Costa Rica )

Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors (CRUCIAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00407537
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : November 11, 2011
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypertension
Hypercholesterolemia
Intervention Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Enrollment 1531
Recruitment Details This was a cluster randomized study: the unit of randomization was the investigator, ie, participants were screened before the investigator was randomized. A total of 136 sites were cluster randomized.
Pre-assignment Details Prior to group assignment of investigators (who were the unit of randomization), participants were consented and screened for enrollment eligibility; participant selection for enrollment took place before investigator assignment. A total of 1,531 participants were enrolled and attended baseline visit; 1,461 participants received treatment.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion. Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Period Title: Overall Study
Started 779 682 [1]
Eligible for Efficacy Analysis 760 657
Completed 686 638
Not Completed 93 44
Reason Not Completed
Death             5             2
Adverse Event             36             0
Lost to Follow-up             12             19
Other             6             7
Withdrawal by Subject             34             16
[1]
4 participants assigned to Caduet treatment received usual care only during the study
Arm/Group Title Caduet as Assigned Usual Care as Assigned Total
Hide Arm/Group Description Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion. Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice. Total of all reporting groups
Overall Number of Baseline Participants 783 678 1461
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 783 participants 678 participants 1461 participants
< 18 years 0 0 0
18 to 44 years 58 55 113
45 to 64 years 450 361 811
> = 65 years 275 262 537
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 783 participants 678 participants 1461 participants
Female
368
  47.0%
334
  49.3%
702
  48.0%
Male
415
  53.0%
344
  50.7%
759
  52.0%
1.Primary Outcome
Title Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
Hide Description Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all subjects, in either treatment group, who had blood pressure and lipid data from at least 1 follow-up visit. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 748 655
Mean (Standard Deviation)
Unit of Measure: percent risk
12.5  (8.26) 16.3  (10.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments It was estimated that each study site would on average complete 8 evaluable participants, therefore enrolling 164 sites, 1968 participants would provide at least 90% power to detect a 10% relative reduction in the 10-year predicted risk of total CHD at 12 months (as calculated from the Framingham model) from the control arm based on a two-sided t-test with a 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -4.72
Confidence Interval (2-Sided) 95%
-5.55 to -3.89
Estimation Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
2.Secondary Outcome
Title Framingham 10-year Risk of Total CHD at Month 4
Hide Description Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 745 637
Mean (Standard Deviation)
Unit of Measure: percent risk
12.5  (7.96) 16.3  (10.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -4.76
Confidence Interval (2-Sided) 95%
-5.58 to -3.93
Estimation Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
3.Secondary Outcome
Title European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 748 655
Mean (Standard Deviation)
Unit of Measure: percent risk
3.0  (2.89) 3.7  (3.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -0.97
Confidence Interval (2-Sided) 95%
-1.23 to -0.72
Estimation Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
4.Secondary Outcome
Title European SCORE 10-year Risk of Fatal CVD at Month 4
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 745 637
Mean (Standard Deviation)
Unit of Measure: percent risk
3.1  (3.13) 3.7  (3.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.16 to -0.59
Estimation Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
5.Secondary Outcome
Title Framingham 10-year Risk of Stroke at Month 12
Hide Description Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific “calibration factor” for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 748 655
Mean (Standard Deviation)
Unit of Measure: percent risk
3.7  (2.25) 4.9  (2.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-1.56 to -1.15
Estimation Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
6.Secondary Outcome
Title Framingham 10-year Risk of Stroke at Month 4
Hide Description Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific “calibration factor” for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 745 637
Mean (Standard Deviation)
Unit of Measure: percent risk
3.7  (2.21) 4.9  (2.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean difference
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-1.57 to -1.14
Estimation Comments Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
7.Secondary Outcome
Title Change From Baseline in Framingham 10-year Risk of Developing Total CHD
Hide Description Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.
Time Frame Baseline, Month 4, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent risk
Month 4
-7.2705
(-7.90 to -6.64)
-2.5155
(-3.19 to -1.84)
Month 12
-7.2374
(-7.87 to -6.61)
-2.5167
(-3.19 to -1.84)
8.Secondary Outcome
Title Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD
Time Frame Baseline, Month 4, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 748 655
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent risk
Month 4
-1.8438
(-2.06 to -1.63)
-0.9678
(-1.20 to -0.74)
Month 12
-1.9693
(-2.16 to -1.77)
-0.9963
(-1.21 to -0.79)
9.Secondary Outcome
Title Mean Systolic and Diastolic Blood Pressure at Month 4
Hide Description [Not Specified]
Time Frame Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 759 657
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic 133.5  (14.32) 134.5  (14.96)
Diastolic 80.7  (8.74) 81.1  (9.32)
10.Secondary Outcome
Title Mean Systolic and Diastolic Blood Pressure at Month 12
Hide Description [Not Specified]
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic 130.6  (13.84) 134.3  (15.21)
Diastolic 79.2  (8.39) 81.1  (9.27)
11.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) at Month 4
Hide Description [Not Specified]
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 759 657
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHG
-15.3088
(-17.02 to -13.60)
-12.1619
(-14.00 to -10.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.007
Comments [Not Specified]
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.15
Confidence Interval (2-Sided) 95%
-5.42 to -0.88
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4
Hide Description [Not Specified]
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 759 657
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHG
-8.3024
(-9.24 to -7.36)
-6.6908
(-7.70 to -5.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.011
Comments [Not Specified]
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.61
Confidence Interval (2-Sided) 95%
-2.86 to -0.37
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in SBP at Month 12
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-18.2409
(-19.94 to -16.55)
-12.4903
(-14.32 to -10.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.75
Confidence Interval (2-Sided) 95%
-8.00 to -3.50
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in DBP at Month 12
Hide Description [Not Specified]
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing to data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmHg
-10.0128
(-10.96 to -9.07)
-6.8429
(-7.86 to -5.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.17
Confidence Interval (2-Sided) 95%
-4.42 to -1.92
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Mean Lipid Parameters at Month 4
Hide Description Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Time Frame Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Mean (Standard Deviation)
Unit of Measure: mg/dL
TC 156.0  (34.14) 195.2  (37.03)
LDL 80.9  (28.47) 116.4  (32.47)
HDL 47.6  (13.93) 46.8  (13.49)
Triglycerides 143.5  (83.26) 164.8  (95.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments TC
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -38.94
Confidence Interval (2-Sided) 95%
-43.71 to -34.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments LDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -35.31
Confidence Interval (2-Sided) 95%
-39.64 to -30.99
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments HDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
-0.14 to 2.13
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments Triglycerides
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effects linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.65
Confidence Interval (2-Sided) 95%
-32.60 to -14.70
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Mean Lipid Parameters at Month 12
Hide Description Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Mean (Standard Deviation)
Unit of Measure: mg/dL
TC 163.3  (38.42) 196.6  (36.36)
LDL 87.1  (32.40) 117.3  (31.57)
HDL 47.3  (13.48) 47.1  (13.61)
Triglycerides 151.5  (98.61) 166.4  (98.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments TC
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -33.07
Confidence Interval (2-Sided) 95%
-37.57 to -28.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments LDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.83
Confidence Interval (2-Sided) 95%
-33.70 to -25.95
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments HDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.379
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
-0.71 to 1.86
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments Triglycerides
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.27
Confidence Interval (2-Sided) 95%
-28.72 to -7.81
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Lipid Parameters at Month 4
Hide Description Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 752 630
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
TC
-42.7542
(-46.35 to -39.15)
-3.8144
(-7.75 to 0.12)
LDL
-38.2765
(-41.52 to -35.03)
-2.9628
(-6.50 to 0.58)
HDL
-0.2060
(-1.07 to 0.65)
-1.1978
(-2.13 to -0.26)
Triglycerides
-20.5645
(-27.30 to -13.83)
3.0828
(-4.26 to 10.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments TC
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -38.94
Confidence Interval (2-Sided) 95%
-43.71 to -34.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments LDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -35.31
Confidence Interval (2-Sided) 95%
-39.64 to -30.99
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments HDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
-0.14 to 2.13
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments Triglycerides
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.65
Confidence Interval (2-Sided) 95%
-32.60 to -14.70
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Lipid Parameters at Month 12
Hide Description Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
TC
-37.1024
(-40.52 to -33.69)
-4.0368
(-7.71 to -0.36)
LDL
-33.2420
(-36.17 to -30.32)
-3.4168
(-6.58 to -0.25)
HDL
-0.4339
(-1.41 to 0.54)
-1.0105
(-2.06 to 0.04)
Triglycerides
-15.2270
(-23.12 to -7.33)
3.0398
(-5.51 to 11.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments Total cholesterol
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -33.07
Confidence Interval (2-Sided) 95%
-37.57 to -28.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments LDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.83
Confidence Interval (2-Sided) 95%
-33.70 to -25.95
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments HDL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.379
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
-0.71 to 1.86
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Caduet, Usual Care
Comments Triglycerides
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.
Method Mixed-effect linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.27
Confidence Interval (2-Sided) 95%
-28.72 to -7.81
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months
Hide Description Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.
Time Frame Month 4, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Measure Type: Number
Unit of Measure: percentage of participants
JNC Month 4 65.2 62.6
JNC Month 12 76.1 60.6
ESC Month 4 48.6 46.0
ESC Month 12 58.2 47.5
20.Secondary Outcome
Title Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months
Hide Description Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.
Time Frame Month 4, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Measure Type: Number
Unit of Measure: Percentage of participants
US Month 4 77.3 28.2
US Month 12 71.9 28.8
EU Month 4 52.4 13.3
EU Month 12 46.7 11.5
21.Secondary Outcome
Title Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months
Hide Description Treatments indicative of prescribed medications other than study provided Caduet.
Time Frame Month 4, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Measure Type: Number
Unit of Measure: participants
Month 4: anti-hypertensive and/or lipid lowering 648 642
Month 4: anti-hypertensive 647 637
Month 4: lipid lowering 45 202
Month 4: anti-hypertensive and lipid lowering 44 197
Month 12: anti-hypertensive and/or lipid lowering 655 642
Month 12: anti-hypertensive 654 638
Month 12: lipid lowering 46 208
Month 12: anti-hypertensive and lipid lowering 45 204
22.Secondary Outcome
Title Number of Participants With Increase of Treatment Dosages After 4 Months.
Hide Description Treatments indicative of prescribed medications other than study provided Caduet.
Time Frame Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Number of participants analyzed refers to number of participants contributing data.
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description:
Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
Overall Number of Participants Analyzed 760 657
Measure Type: Number
Unit of Measure: Participants
Increased dose 30 90
increased dose of anti-hypertensive medications 30 88
increased dose of lipid lowering medications 0 2
increase in either medication 4 45
increase in both medications 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Caduet Usual Care
Hide Arm/Group Description Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion. Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
All-Cause Mortality
Caduet Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Caduet Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   51/779 (6.55%)   22/682 (3.23%) 
Blood and lymphatic system disorders     
Anaemia  1  0/779 (0.00%)  1/682 (0.15%) 
Cardiac disorders     
Acute coronary syndrome  1  1/779 (0.13%)  0/682 (0.00%) 
Acute myocardial infarction  1  2/779 (0.26%)  2/682 (0.29%) 
Angina pectoris  1  1/779 (0.13%)  0/682 (0.00%) 
Angina unstable  1  1/779 (0.13%)  1/682 (0.15%) 
Arteriosclerosis coronary artery  1  0/779 (0.00%)  1/682 (0.15%) 
Atrial fibrillation  1  1/779 (0.13%)  1/682 (0.15%) 
Bradycardia  1  1/779 (0.13%)  0/682 (0.00%) 
Cardiac arrest  1  1/779 (0.13%)  0/682 (0.00%) 
Cardiac failure  1  1/779 (0.13%)  0/682 (0.00%) 
Cardiac failure congestive  1  0/779 (0.00%)  1/682 (0.15%) 
Coronary artery disease  1  1/779 (0.13%)  0/682 (0.00%) 
Myocardial infarction  1  2/779 (0.26%)  0/682 (0.00%) 
Myocardial ischaemia  1  0/779 (0.00%)  2/682 (0.29%) 
Ear and labyrinth disorders     
Vertigo  1  1/779 (0.13%)  0/682 (0.00%) 
Eye disorders     
Macular hole  1  1/779 (0.13%)  0/682 (0.00%) 
Normal tension glaucoma  1  1/779 (0.13%)  0/682 (0.00%) 
Vitreous haemorrhage  1  1/779 (0.13%)  0/682 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/779 (0.13%)  0/682 (0.00%) 
Dysphagia  1  1/779 (0.13%)  0/682 (0.00%) 
General disorders     
Chest discomfort  1  1/779 (0.13%)  0/682 (0.00%) 
Chest pain  1  2/779 (0.26%)  0/682 (0.00%) 
Oedema  1  1/779 (0.13%)  0/682 (0.00%) 
Oedema peripheral  1  1/779 (0.13%)  0/682 (0.00%) 
Sudden cardiac death  1  1/779 (0.13%)  0/682 (0.00%) 
Hepatobiliary disorders     
Biliary colic  1  1/779 (0.13%)  0/682 (0.00%) 
Cholestasis  1  1/779 (0.13%)  0/682 (0.00%) 
Hepatic function abnormal  1  1/779 (0.13%)  0/682 (0.00%) 
Jaundice  1  1/779 (0.13%)  0/682 (0.00%) 
Infections and infestations     
Acute sinusitis  1  1/779 (0.13%)  0/682 (0.00%) 
Appendicitis  1  2/779 (0.26%)  1/682 (0.15%) 
Arthritis infective  1  1/779 (0.13%)  0/682 (0.00%) 
Infection  1  0/779 (0.00%)  1/682 (0.15%) 
Lower respiratory tract infection  1  1/779 (0.13%)  0/682 (0.00%) 
Pneumonia  1  2/779 (0.26%)  0/682 (0.00%) 
Urinary tract infection  1  3/779 (0.39%)  0/682 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/779 (0.13%)  0/682 (0.00%) 
Fractured coccyx  1  0/779 (0.00%)  1/682 (0.15%) 
Hand fracture  1  1/779 (0.13%)  0/682 (0.00%) 
Head injury  1  0/779 (0.00%)  1/682 (0.15%) 
Hip fracture  1  0/779 (0.00%)  1/682 (0.15%) 
Humerus fracture  1  0/779 (0.00%)  1/682 (0.15%) 
Tendon rupture  1  1/779 (0.13%)  0/682 (0.00%) 
Upper limb fracture  1  0/779 (0.00%)  1/682 (0.15%) 
Investigations     
Electrocardiogram T wave inversion  1  0/779 (0.00%)  1/682 (0.15%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  2/779 (0.26%)  0/682 (0.00%) 
Hypertriglyceridaemia  1  1/779 (0.13%)  0/682 (0.00%) 
Musculoskeletal and connective tissue disorders     
Rotator cuff syndrome  1  1/779 (0.13%)  0/682 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adrenal adenoma  1  1/779 (0.13%)  0/682 (0.00%) 
Lipoma  1  1/779 (0.13%)  0/682 (0.00%) 
Lung neoplasm malignant  1  0/779 (0.00%)  1/682 (0.15%) 
Metastases to liver  1  0/779 (0.00%)  1/682 (0.15%) 
Metastases to peritoneum  1  0/779 (0.00%)  1/682 (0.15%) 
Non-Hodgkin’s lymphoma  1  1/779 (0.13%)  0/682 (0.00%) 
Pancreatic carcinoma  1  2/779 (0.26%)  0/682 (0.00%) 
Prostate cancer  1  1/779 (0.13%)  0/682 (0.00%) 
Rectal cancer  1  0/779 (0.00%)  1/682 (0.15%) 
Nervous system disorders     
Cerebellar infarction  1  1/779 (0.13%)  0/682 (0.00%) 
Cerebrovascular accident  1  1/779 (0.13%)  1/682 (0.15%) 
Cerebrovascular disorder  1  0/779 (0.00%)  1/682 (0.15%) 
Facial palsy  1  0/779 (0.00%)  1/682 (0.15%) 
Hemiparesis  1  1/779 (0.13%)  0/682 (0.00%) 
Ischaemic stroke  1  2/779 (0.26%)  0/682 (0.00%) 
Thrombotic stroke  1  1/779 (0.13%)  0/682 (0.00%) 
Transient ischaemic attack  1  0/779 (0.00%)  1/682 (0.15%) 
Upper motor neurone lesion  1  1/779 (0.13%)  0/682 (0.00%) 
Psychiatric disorders     
Depression  1  1/779 (0.13%)  0/682 (0.00%) 
Panic attack  1  0/779 (0.00%)  1/682 (0.15%) 
Renal and urinary disorders     
Choluria  1  1/779 (0.13%)  0/682 (0.00%) 
Hydronephrosis  1  1/779 (0.13%)  0/682 (0.00%) 
Renal cyst  1  1/779 (0.13%)  0/682 (0.00%) 
Renal disorder  1  0/779 (0.00%)  1/682 (0.15%) 
Renal failure  1  1/779 (0.13%)  0/682 (0.00%) 
Renal mass  1  1/779 (0.13%)  0/682 (0.00%) 
Reproductive system and breast disorders     
Endometriosis  1  0/779 (0.00%)  1/682 (0.15%) 
Prostatitis  1  1/779 (0.13%)  0/682 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/779 (0.13%)  0/682 (0.00%) 
Chronic obstructive pulmonary disease  1  0/779 (0.00%)  1/682 (0.15%) 
Vascular disorders     
Hypertensive crisis  1  1/779 (0.13%)  0/682 (0.00%) 
Thrombophlebitis  1  1/779 (0.13%)  0/682 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Caduet Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   356/779 (45.70%)   289/682 (42.38%) 
Blood and lymphatic system disorders     
Anaemia  1  1/779 (0.13%)  1/682 (0.15%) 
Lymphadenitis  1  0/779 (0.00%)  1/682 (0.15%) 
Lymphadenopathy  1  1/779 (0.13%)  0/682 (0.00%) 
Normochromic normocytic anaemia  1  1/779 (0.13%)  0/682 (0.00%) 
Cardiac disorders     
Angina pectoris  1  2/779 (0.26%)  0/682 (0.00%) 
Angina unstable  1  0/779 (0.00%)  1/682 (0.15%) 
Atrial fibrillation  1  1/779 (0.13%)  1/682 (0.15%) 
Bradyarrhythmia  1  1/779 (0.13%)  0/682 (0.00%) 
Bradycardia  1  1/779 (0.13%)  0/682 (0.00%) 
Coronary artery disease  1  0/779 (0.00%)  1/682 (0.15%) 
Left ventricular hypertrophy  1  1/779 (0.13%)  0/682 (0.00%) 
Myocardial ischaemia  1  1/779 (0.13%)  0/682 (0.00%) 
Palpitations  1  9/779 (1.16%)  5/682 (0.73%) 
Supraventricular tachyarrhythmia  1  0/779 (0.00%)  1/682 (0.15%) 
Supraventricular tachycardia  1  1/779 (0.13%)  0/682 (0.00%) 
Tachycardia  1  2/779 (0.26%)  0/682 (0.00%) 
Ventricular extrasystoles  1  1/779 (0.13%)  1/682 (0.15%) 
Congenital, familial and genetic disorders     
Corneal dystrophy  1  0/779 (0.00%)  1/682 (0.15%) 
Ear and labyrinth disorders     
Deafness unilateral  1  1/779 (0.13%)  0/682 (0.00%) 
Hearing impaired  1  0/779 (0.00%)  1/682 (0.15%) 
Hypoacusis  1  0/779 (0.00%)  1/682 (0.15%) 
Inner ear disorder  1  1/779 (0.13%)  0/682 (0.00%) 
Otosclerosis  1  1/779 (0.13%)  0/682 (0.00%) 
Tinnitus  1  1/779 (0.13%)  0/682 (0.00%) 
Vertigo  1  3/779 (0.39%)  4/682 (0.59%) 
Vertigo positional  1  1/779 (0.13%)  0/682 (0.00%) 
Endocrine disorders     
Goitre  1  1/779 (0.13%)  0/682 (0.00%) 
Thyroid cyst  1  1/779 (0.13%)  0/682 (0.00%) 
Thyroid mass  1  0/779 (0.00%)  1/682 (0.15%) 
Eye disorders     
Abnormal sensation in eye  1  0/779 (0.00%)  1/682 (0.15%) 
Cataract  1  5/779 (0.64%)  3/682 (0.44%) 
Chalazion  1  1/779 (0.13%)  0/682 (0.00%) 
Conjunctivitis  1  4/779 (0.51%)  3/682 (0.44%) 
Conjunctivitis allergic  1  0/779 (0.00%)  2/682 (0.29%) 
Diabetic retinopathy  1  0/779 (0.00%)  1/682 (0.15%) 
Iridocyclitis  1  1/779 (0.13%)  0/682 (0.00%) 
Iritis  1  1/779 (0.13%)  0/682 (0.00%) 
Keratitis  1  0/779 (0.00%)  1/682 (0.15%) 
Macular hole  1  1/779 (0.13%)  0/682 (0.00%) 
Posterior capsule opacification  1  2/779 (0.26%)  0/682 (0.00%) 
Refraction disorder  1  0/779 (0.00%)  1/682 (0.15%) 
Retinal vein occlusion  1  0/779 (0.00%)  1/682 (0.15%) 
Retinopathy  1  1/779 (0.13%)  0/682 (0.00%) 
Trichiasis  1  2/779 (0.26%)  0/682 (0.00%) 
Vision blurred  1  3/779 (0.39%)  0/682 (0.00%) 
Visual impairment  1  1/779 (0.13%)  0/682 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/779 (0.13%)  0/682 (0.00%) 
Abdominal pain  1  2/779 (0.26%)  2/682 (0.29%) 
Abdominal pain upper  1  7/779 (0.90%)  7/682 (1.03%) 
Colitis  1  0/779 (0.00%)  2/682 (0.29%) 
Colonic polyp  1  0/779 (0.00%)  1/682 (0.15%) 
Constipation  1  9/779 (1.16%)  4/682 (0.59%) 
Diabetic enteropathy  1  0/779 (0.00%)  1/682 (0.15%) 
Diarrhoea  1  7/779 (0.90%)  1/682 (0.15%) 
Dry mouth  1  1/779 (0.13%)  0/682 (0.00%) 
Dyspepsia  1  5/779 (0.64%)  10/682 (1.47%) 
Epigastric discomfort  1  1/779 (0.13%)  0/682 (0.00%) 
Flatulence  1  0/779 (0.00%)  1/682 (0.15%) 
Gastric ulcer  1  2/779 (0.26%)  1/682 (0.15%) 
Gastric ulcer haemorrhage  1  1/779 (0.13%)  0/682 (0.00%) 
Gastritis  1  4/779 (0.51%)  6/682 (0.88%) 
Gastritis erosive  1  1/779 (0.13%)  1/682 (0.15%) 
Gastrointestinal disorder  1  2/779 (0.26%)  0/682 (0.00%) 
Gastrooesophageal reflux disease  1  2/779 (0.26%)  2/682 (0.29%) 
Gingival erythema  1  1/779 (0.13%)  0/682 (0.00%) 
Gingival hyperplasia  1  0/779 (0.00%)  1/682 (0.15%) 
Gingival swelling  1  1/779 (0.13%)  0/682 (0.00%) 
Glossodynia  1  0/779 (0.00%)  1/682 (0.15%) 
Haemorrhoids  1  2/779 (0.26%)  1/682 (0.15%) 
Irritable bowel syndrome  1  1/779 (0.13%)  3/682 (0.44%) 
Lip swelling  1  1/779 (0.13%)  0/682 (0.00%) 
Mouth ulceration  1  0/779 (0.00%)  2/682 (0.29%) 
Nausea  1  2/779 (0.26%)  1/682 (0.15%) 
Oedema mouth  1  1/779 (0.13%)  0/682 (0.00%) 
Oesophagitis  1  1/779 (0.13%)  0/682 (0.00%) 
Peptic ulcer  1  0/779 (0.00%)  3/682 (0.44%) 
Periodontitis  1  1/779 (0.13%)  1/682 (0.15%) 
Rectal polyp  1  0/779 (0.00%)  1/682 (0.15%) 
Reflux oesophagitis  1  1/779 (0.13%)  1/682 (0.15%) 
Vomiting  1  2/779 (0.26%)  0/682 (0.00%) 
General disorders     
Asthenia  1  3/779 (0.39%)  1/682 (0.15%) 
Chest discomfort  1  4/779 (0.51%)  4/682 (0.59%) 
Chest pain  1  16/779 (2.05%)  10/682 (1.47%) 
Drug ineffective  1  0/779 (0.00%)  1/682 (0.15%) 
Face oedema  1  1/779 (0.13%)  0/682 (0.00%) 
Fatigue  1  4/779 (0.51%)  3/682 (0.44%) 
Generalised oedema  1  1/779 (0.13%)  0/682 (0.00%) 
Impaired healing  1  1/779 (0.13%)  0/682 (0.00%) 
Malaise  1  2/779 (0.26%)  0/682 (0.00%) 
Oedema  1  11/779 (1.41%)  1/682 (0.15%) 
Oedema peripheral  1  52/779 (6.68%)  11/682 (1.61%) 
Pain  1  1/779 (0.13%)  0/682 (0.00%) 
Pyrexia  1  3/779 (0.39%)  2/682 (0.29%) 
Swelling  1  0/779 (0.00%)  1/682 (0.15%) 
Tenderness  1  1/779 (0.13%)  0/682 (0.00%) 
Thirst  1  1/779 (0.13%)  0/682 (0.00%) 
Hepatobiliary disorders     
Biliary colic  1  0/779 (0.00%)  1/682 (0.15%) 
Cholecystitis  1  1/779 (0.13%)  1/682 (0.15%) 
Cholecystitis acute  1  0/779 (0.00%)  1/682 (0.15%) 
Cholelithiasis  1  1/779 (0.13%)  0/682 (0.00%) 
Hepatic function abnormal  1  0/779 (0.00%)  3/682 (0.44%) 
Hepatic steatosis  1  1/779 (0.13%)  3/682 (0.44%) 
Immune system disorders     
Allergy to arthropod sting  1  1/779 (0.13%)  1/682 (0.15%) 
Hypersensitivity  1  1/779 (0.13%)  0/682 (0.00%) 
Infections and infestations     
Acute sinusitis  1  1/779 (0.13%)  5/682 (0.73%) 
Bacterial infection  1  2/779 (0.26%)  0/682 (0.00%) 
Borrelia infection  1  0/779 (0.00%)  1/682 (0.15%) 
Bronchitis  1  12/779 (1.54%)  15/682 (2.20%) 
Bronchitis viral  1  0/779 (0.00%)  1/682 (0.15%) 
Campylobacter intestinal infection  1  0/779 (0.00%)  1/682 (0.15%) 
Catheter site infection  1  0/779 (0.00%)  1/682 (0.15%) 
Cellulitis  1  1/779 (0.13%)  1/682 (0.15%) 
Conjunctivitis infective  1  1/779 (0.13%)  0/682 (0.00%) 
Cystitis  1  4/779 (0.51%)  2/682 (0.29%) 
Eczema infected  1  0/779 (0.00%)  1/682 (0.15%) 
Folliculitis  1  1/779 (0.13%)  0/682 (0.00%) 
Fungal skin infection  1  1/779 (0.13%)  0/682 (0.00%) 
Gastroenteritis  1  1/779 (0.13%)  3/682 (0.44%) 
Gingival infection  1  0/779 (0.00%)  1/682 (0.15%) 
Hepatitis B  1  1/779 (0.13%)  0/682 (0.00%) 
Herpes zoster  1  2/779 (0.26%)  3/682 (0.44%) 
Influenza  1  7/779 (0.90%)  3/682 (0.44%) 
Labyrinthitis  1  0/779 (0.00%)  1/682 (0.15%) 
Laryngitis  1  1/779 (0.13%)  0/682 (0.00%) 
Localised infection  1  0/779 (0.00%)  1/682 (0.15%) 
Nasopharyngitis  1  22/779 (2.82%)  10/682 (1.47%) 
Onychomycosis  1  0/779 (0.00%)  2/682 (0.29%) 
Oral herpes  1  0/779 (0.00%)  1/682 (0.15%) 
Otitis media  1  1/779 (0.13%)  1/682 (0.15%) 
Paronychia  1  1/779 (0.13%)  0/682 (0.00%) 
Peritonsillar abscess  1  1/779 (0.13%)  0/682 (0.00%) 
Pharyngitis  1  6/779 (0.77%)  13/682 (1.91%) 
Pharyngotonsillitis  1  0/779 (0.00%)  1/682 (0.15%) 
Pneumonia  1  0/779 (0.00%)  1/682 (0.15%) 
Pulpitis dental  1  0/779 (0.00%)  1/682 (0.15%) 
Pyelonephritis acute  1  0/779 (0.00%)  1/682 (0.15%) 
Rash pustular  1  0/779 (0.00%)  1/682 (0.15%) 
Respiratory tract infection  1  0/779 (0.00%)  2/682 (0.29%) 
Respiratory tract infection bacterial  1  0/779 (0.00%)  1/682 (0.15%) 
Respiratory tract infection viral  1  1/779 (0.13%)  7/682 (1.03%) 
Rhinitis  1  0/779 (0.00%)  1/682 (0.15%) 
Sinusitis  1  2/779 (0.26%)  0/682 (0.00%) 
Sinusitis bacterial  1  0/779 (0.00%)  1/682 (0.15%) 
Skin candida  1  1/779 (0.13%)  0/682 (0.00%) 
Skin infection  1  1/779 (0.13%)  1/682 (0.15%) 
Tinea pedis  1  0/779 (0.00%)  1/682 (0.15%) 
Tonsillitis  1  0/779 (0.00%)  1/682 (0.15%) 
Tracheitis  1  1/779 (0.13%)  0/682 (0.00%) 
Tracheobronchitis  1  1/779 (0.13%)  0/682 (0.00%) 
Upper respiratory tract infection  1  16/779 (2.05%)  14/682 (2.05%) 
Urethritis  1  1/779 (0.13%)  0/682 (0.00%) 
Urinary tract infection  1  2/779 (0.26%)  6/682 (0.88%) 
Urogenital infection fungal  1  1/779 (0.13%)  0/682 (0.00%) 
Vaginal infection  1  0/779 (0.00%)  1/682 (0.15%) 
Viral infection  1  1/779 (0.13%)  0/682 (0.00%) 
Injury, poisoning and procedural complications     
Brain contusion  1  0/779 (0.00%)  1/682 (0.15%) 
Contusion  1  1/779 (0.13%)  3/682 (0.44%) 
Excoriation  1  1/779 (0.13%)  1/682 (0.15%) 
Eye injury  1  1/779 (0.13%)  0/682 (0.00%) 
Facial bones fracture  1  0/779 (0.00%)  1/682 (0.15%) 
Foreign body trauma  1  1/779 (0.13%)  0/682 (0.00%) 
Head injury  1  1/779 (0.13%)  0/682 (0.00%) 
Injury  1  1/779 (0.13%)  0/682 (0.00%) 
Joint injury  1  1/779 (0.13%)  0/682 (0.00%) 
Joint sprain  1  2/779 (0.26%)  3/682 (0.44%) 
Ligament sprain  1  0/779 (0.00%)  1/682 (0.15%) 
Limb injury  1  1/779 (0.13%)  0/682 (0.00%) 
Medication error  1  3/779 (0.39%)  0/682 (0.00%) 
Muscle injury  1  0/779 (0.00%)  1/682 (0.15%) 
Nerve root injury cervical  1  1/779 (0.13%)  0/682 (0.00%) 
Radius fracture  1  1/779 (0.13%)  0/682 (0.00%) 
Road traffic accident  1  2/779 (0.26%)  0/682 (0.00%) 
Skin laceration  1  1/779 (0.13%)  1/682 (0.15%) 
Thermal burn  1  0/779 (0.00%)  1/682 (0.15%) 
Tooth injury  1  0/779 (0.00%)  1/682 (0.15%) 
Wound  1  1/779 (0.13%)  0/682 (0.00%) 
Wrist fracture  1  1/779 (0.13%)  0/682 (0.00%) 
Investigations     
Alanine aminotransferase decreased  1  0/779 (0.00%)  1/682 (0.15%) 
Alanine aminotransferase increased  1  5/779 (0.64%)  2/682 (0.29%) 
Aspartate aminotransferase increased  1  5/779 (0.64%)  2/682 (0.29%) 
Blood albumin decreased  1  0/779 (0.00%)  1/682 (0.15%) 
Blood alkaline phosphatase increased  1  3/779 (0.39%)  2/682 (0.29%) 
Blood calcium decreased  1  0/779 (0.00%)  1/682 (0.15%) 
Blood calcium increased  1  0/779 (0.00%)  1/682 (0.15%) 
Blood cholesterol increased  1  0/779 (0.00%)  2/682 (0.29%) 
Blood creatine increased  1  1/779 (0.13%)  1/682 (0.15%) 
Blood creatine phosphokinase increased  1  15/779 (1.93%)  5/682 (0.73%) 
Blood creatinine increased  1  6/779 (0.77%)  0/682 (0.00%) 
Blood glucose decreased  1  1/779 (0.13%)  0/682 (0.00%) 
Blood glucose increased  1  8/779 (1.03%)  3/682 (0.44%) 
Blood potassium decreased  1  1/779 (0.13%)  0/682 (0.00%) 
Blood potassium increased  1  0/779 (0.00%)  3/682 (0.44%) 
Blood pressure abnormal  1  1/779 (0.13%)  0/682 (0.00%) 
Blood pressure increased  1  1/779 (0.13%)  2/682 (0.29%) 
Blood triglycerides increased  1  11/779 (1.41%)  14/682 (2.05%) 
Blood urea increased  1  2/779 (0.26%)  1/682 (0.15%) 
Blood uric acid increased  1  0/779 (0.00%)  2/682 (0.29%) 
ECG signs of myocardial ischaemia  1  0/779 (0.00%)  1/682 (0.15%) 
Glycosylated haemoglobin increased  1  1/779 (0.13%)  0/682 (0.00%) 
Heart rate irregular  1  1/779 (0.13%)  0/682 (0.00%) 
High density lipoprotein increased  1  1/779 (0.13%)  0/682 (0.00%) 
Lipids increased  1  0/779 (0.00%)  1/682 (0.15%) 
Platelet aggregation increased  1  0/779 (0.00%)  1/682 (0.15%) 
Weight decreased  1  1/779 (0.13%)  0/682 (0.00%) 
Weight increased  1  1/779 (0.13%)  0/682 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/779 (0.00%)  1/682 (0.15%) 
Dehydration  1  1/779 (0.13%)  0/682 (0.00%) 
Diabetes mellitus  1  4/779 (0.51%)  3/682 (0.44%) 
Diabetes mellitus inadequate control  1  0/779 (0.00%)  1/682 (0.15%) 
Dyslipidaemia  1  0/779 (0.00%)  11/682 (1.61%) 
Food intolerance  1  1/779 (0.13%)  0/682 (0.00%) 
Glucose tolerance impaired  1  0/779 (0.00%)  1/682 (0.15%) 
Gout  1  1/779 (0.13%)  0/682 (0.00%) 
Hypercalcaemia  1  0/779 (0.00%)  2/682 (0.29%) 
Hypercholesterolaemia  1  1/779 (0.13%)  12/682 (1.76%) 
Hypercreatininaemia  1  0/779 (0.00%)  3/682 (0.44%) 
Hyperglycaemia  1  5/779 (0.64%)  8/682 (1.17%) 
Hyperkalaemia  1  0/779 (0.00%)  1/682 (0.15%) 
Hyperlipidaemia  1  0/779 (0.00%)  10/682 (1.47%) 
Hypertriglyceridaemia  1  1/779 (0.13%)  7/682 (1.03%) 
Hyperuricaemia  1  0/779 (0.00%)  4/682 (0.59%) 
Hypo HDL cholesterolaemia  1  1/779 (0.13%)  1/682 (0.15%) 
Hypocalcaemia  1  0/779 (0.00%)  1/682 (0.15%) 
Hypoglycaemia  1  1/779 (0.13%)  5/682 (0.73%) 
Hypokalaemia  1  0/779 (0.00%)  3/682 (0.44%) 
Hyponatraemia  1  0/779 (0.00%)  1/682 (0.15%) 
Type 2 diabetes mellitus  1  1/779 (0.13%)  0/682 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/779 (1.28%)  8/682 (1.17%) 
Arthritis  1  0/779 (0.00%)  1/682 (0.15%) 
Back pain  1  12/779 (1.54%)  6/682 (0.88%) 
Bone disorder  1  0/779 (0.00%)  1/682 (0.15%) 
Bursitis  1  2/779 (0.26%)  1/682 (0.15%) 
Crystal arthropathy  1  1/779 (0.13%)  0/682 (0.00%) 
Exostosis  1  0/779 (0.00%)  2/682 (0.29%) 
Flank pain  1  0/779 (0.00%)  1/682 (0.15%) 
Groin pain  1  0/779 (0.00%)  1/682 (0.15%) 
Joint swelling  1  2/779 (0.26%)  0/682 (0.00%) 
Monarthritis  1  2/779 (0.26%)  0/682 (0.00%) 
Muscle contracture  1  0/779 (0.00%)  1/682 (0.15%) 
Muscle haemorrhage  1  1/779 (0.13%)  0/682 (0.00%) 
Muscle spasms  1  4/779 (0.51%)  1/682 (0.15%) 
Muscular weakness  1  1/779 (0.13%)  0/682 (0.00%) 
Musculoskeletal chest pain  1  0/779 (0.00%)  1/682 (0.15%) 
Musculoskeletal pain  1  5/779 (0.64%)  2/682 (0.29%) 
Musculoskeletal stiffness  1  1/779 (0.13%)  0/682 (0.00%) 
Myalgia  1  7/779 (0.90%)  5/682 (0.73%) 
Myositis  1  1/779 (0.13%)  1/682 (0.15%) 
Neck pain  1  3/779 (0.39%)  4/682 (0.59%) 
Osteoarthritis  1  10/779 (1.28%)  8/682 (1.17%) 
Osteochondrosis  1  0/779 (0.00%)  3/682 (0.44%) 
Osteoporosis  1  0/779 (0.00%)  2/682 (0.29%) 
Pain in extremity  1  5/779 (0.64%)  5/682 (0.73%) 
Periarthritis  1  3/779 (0.39%)  0/682 (0.00%) 
Plantar fasciitis  1  1/779 (0.13%)  0/682 (0.00%) 
Polyarthritis  1  1/779 (0.13%)  0/682 (0.00%) 
Rheumatoid arthritis  1  1/779 (0.13%)  0/682 (0.00%) 
Senile osteoporosis  1  1/779 (0.13%)  0/682 (0.00%) 
Spinal column stenosis  1  0/779 (0.00%)  1/682 (0.15%) 
Spinal osteoarthritis  1  3/779 (0.39%)  1/682 (0.15%) 
Sympathetic posterior cervical syndrome  1  0/779 (0.00%)  2/682 (0.29%) 
Temporomandibular joint syndrome  1  0/779 (0.00%)  1/682 (0.15%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/779 (0.00%)  1/682 (0.15%) 
Lipoma  1  1/779 (0.13%)  0/682 (0.00%) 
Neoplasm  1  1/779 (0.13%)  0/682 (0.00%) 
Uterine leiomyoma  1  0/779 (0.00%)  2/682 (0.29%) 
Nervous system disorders     
Balance disorder  1  1/779 (0.13%)  0/682 (0.00%) 
Carotid arteriosclerosis  1  0/779 (0.00%)  1/682 (0.15%) 
Carpal tunnel syndrome  1  1/779 (0.13%)  0/682 (0.00%) 
Cerebral atrophy  1  0/779 (0.00%)  1/682 (0.15%) 
Cervicobrachial syndrome  1  1/779 (0.13%)  1/682 (0.15%) 
Dementia  1  0/779 (0.00%)  1/682 (0.15%) 
Diabetic neuropathy  1  1/779 (0.13%)  2/682 (0.29%) 
Dizziness  1  17/779 (2.18%)  9/682 (1.32%) 
Dizziness postural  1  0/779 (0.00%)  2/682 (0.29%) 
Head discomfort  1  1/779 (0.13%)  0/682 (0.00%) 
Headache  1  23/779 (2.95%)  15/682 (2.20%) 
Hypoaesthesia  1  8/779 (1.03%)  0/682 (0.00%) 
Lumbar radiculopathy  1  0/779 (0.00%)  1/682 (0.15%) 
Nerve root lesion  1  1/779 (0.13%)  0/682 (0.00%) 
Neuropathy peripheral  1  1/779 (0.13%)  2/682 (0.29%) 
Paraesthesia  1  2/779 (0.26%)  2/682 (0.29%) 
Restless legs syndrome  1  1/779 (0.13%)  0/682 (0.00%) 
Sciatica  1  3/779 (0.39%)  1/682 (0.15%) 
Tension headache  1  1/779 (0.13%)  0/682 (0.00%) 
Tremor  1  0/779 (0.00%)  1/682 (0.15%) 
Psychiatric disorders     
Anxiety  1  2/779 (0.26%)  5/682 (0.73%) 
Bruxism  1  0/779 (0.00%)  1/682 (0.15%) 
Depression  1  4/779 (0.51%)  4/682 (0.59%) 
Insomnia  1  8/779 (1.03%)  11/682 (1.61%) 
Neurosis  1  0/779 (0.00%)  1/682 (0.15%) 
Tic  1  1/779 (0.13%)  0/682 (0.00%) 
Renal and urinary disorders     
Calculus bladder  1  0/779 (0.00%)  1/682 (0.15%) 
Calculus ureteric  1  0/779 (0.00%)  1/682 (0.15%) 
Cystitis haemorrhagic  1  1/779 (0.13%)  0/682 (0.00%) 
Diabetic nephropathy  1  1/779 (0.13%)  1/682 (0.15%) 
Dysuria  1  1/779 (0.13%)  1/682 (0.15%) 
Haematuria  1  2/779 (0.26%)  0/682 (0.00%) 
Nocturia  1  1/779 (0.13%)  0/682 (0.00%) 
Renal cyst  1  2/779 (0.26%)  0/682 (0.00%) 
Renal disorder  1  1/779 (0.13%)  0/682 (0.00%) 
Renal failure  1  0/779 (0.00%)  1/682 (0.15%) 
Renal failure chronic  1  0/779 (0.00%)  1/682 (0.15%) 
Renal impairment  1  0/779 (0.00%)  1/682 (0.15%) 
Urinary incontinence  1  1/779 (0.13%)  0/682 (0.00%) 
Reproductive system and breast disorders     
Atrophic vulvovaginitis  1  1/779 (0.13%)  0/682 (0.00%) 
Benign prostatic hyperplasia  1  0/779 (0.00%)  1/682 (0.15%) 
Endometrial hypertrophy  1  1/779 (0.13%)  0/682 (0.00%) 
Erectile dysfunction  1  2/779 (0.26%)  1/682 (0.15%) 
Metrorrhagia  1  0/779 (0.00%)  1/682 (0.15%) 
Pelvic pain  1  0/779 (0.00%)  1/682 (0.15%) 
Prostatomegaly  1  1/779 (0.13%)  0/682 (0.00%) 
Vaginal haemorrhage  1  0/779 (0.00%)  1/682 (0.15%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/779 (0.13%)  1/682 (0.15%) 
Bronchial hyperreactivity  1  1/779 (0.13%)  0/682 (0.00%) 
Bronchospasm  1  0/779 (0.00%)  2/682 (0.29%) 
Chronic obstructive pulmonary disease  1  0/779 (0.00%)  1/682 (0.15%) 
Cough  1  9/779 (1.16%)  8/682 (1.17%) 
Diaphragmatic hernia  1  1/779 (0.13%)  0/682 (0.00%) 
Dyspnoea  1  5/779 (0.64%)  4/682 (0.59%) 
Dyspnoea exertional  1  1/779 (0.13%)  0/682 (0.00%) 
Epistaxis  1  0/779 (0.00%)  2/682 (0.29%) 
Hypoxia  1  0/779 (0.00%)  1/682 (0.15%) 
Oropharyngeal discomfort  1  0/779 (0.00%)  1/682 (0.15%) 
Oropharyngeal pain  1  1/779 (0.13%)  0/682 (0.00%) 
Paranasal cyst  1  1/779 (0.13%)  0/682 (0.00%) 
Respiratory disorder  1  5/779 (0.64%)  0/682 (0.00%) 
Rhinitis allergic  1  2/779 (0.26%)  1/682 (0.15%) 
Rhinorrhoea  1  2/779 (0.26%)  1/682 (0.15%) 
Throat irritation  1  1/779 (0.13%)  0/682 (0.00%) 
Tonsillar inflammation  1  1/779 (0.13%)  0/682 (0.00%) 
Upper airway obstruction  1  1/779 (0.13%)  0/682 (0.00%) 
Vocal cord polyp  1  0/779 (0.00%)  1/682 (0.15%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  0/779 (0.00%)  1/682 (0.15%) 
Dermatitis  1  2/779 (0.26%)  1/682 (0.15%) 
Dermatitis allergic  1  1/779 (0.13%)  0/682 (0.00%) 
Dermatitis atopic  1  0/779 (0.00%)  1/682 (0.15%) 
Dermatosis  1  0/779 (0.00%)  1/682 (0.15%) 
Eczema  1  0/779 (0.00%)  1/682 (0.15%) 
Erythema  1  5/779 (0.64%)  2/682 (0.29%) 
Hyperhidrosis  1  1/779 (0.13%)  0/682 (0.00%) 
Neurodermatitis  1  0/779 (0.00%)  1/682 (0.15%) 
Pruritus  1  5/779 (0.64%)  1/682 (0.15%) 
Pruritus allergic  1  1/779 (0.13%)  0/682 (0.00%) 
Psoriasis  1  1/779 (0.13%)  0/682 (0.00%) 
Rash  1  4/779 (0.51%)  1/682 (0.15%) 
Rash papular  1  1/779 (0.13%)  0/682 (0.00%) 
Seborrhoeic dermatitis  1  1/779 (0.13%)  0/682 (0.00%) 
Skin hypopigmentation  1  1/779 (0.13%)  0/682 (0.00%) 
Urticaria  1  1/779 (0.13%)  1/682 (0.15%) 
Surgical and medical procedures     
Cataract operation  1  1/779 (0.13%)  0/682 (0.00%) 
Circumcision  1  1/779 (0.13%)  0/682 (0.00%) 
Intraocular lens implant  1  1/779 (0.13%)  1/682 (0.15%) 
Lipoma excision  1  0/779 (0.00%)  1/682 (0.15%) 
Vascular disorders     
Flushing  1  3/779 (0.39%)  0/682 (0.00%) 
Haematoma  1  0/779 (0.00%)  2/682 (0.29%) 
Hypertension  1  6/779 (0.77%)  12/682 (1.76%) 
Hypotension  1  9/779 (1.16%)  4/682 (0.59%) 
Intermittent claudication  1  2/779 (0.26%)  0/682 (0.00%) 
Labile blood pressure  1  0/779 (0.00%)  1/682 (0.15%) 
Orthostatic hypotension  1  1/779 (0.13%)  1/682 (0.15%) 
Peripheral ischaemia  1  1/779 (0.13%)  0/682 (0.00%) 
Thrombophlebitis superficial  1  1/779 (0.13%)  1/682 (0.15%) 
Venous insufficiency  1  0/779 (0.00%)  2/682 (0.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00407537     History of Changes
Other Study ID Numbers: A3841047
First Submitted: December 1, 2006
First Posted: December 5, 2006
Results First Submitted: October 6, 2010
Results First Posted: November 11, 2011
Last Update Posted: July 23, 2015