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MK0524B Bioequivalence Study (0524B-070)

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ClinicalTrials.gov Identifier: NCT00943124
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : January 6, 2010
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dyslipidemia
Interventions Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)
Drug: MK0524A (ER niacin + laropiprant)
Drug: Simvastatin
Enrollment 220
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK0524B Then Simvastatin + MK0524A Simvastatin + MK0524A Then MK0524B
Hide Arm/Group Description

Period 1: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet).

Period 2: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets.

Period 1: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets.

Period 2: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet).

Period Title: Period 1
Started 110 110
Completed 108 108
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             1             1
Did Not Follow Study Procedures             1             0
Personal Reasons             0             1
Period Title: Period 2
Started 108 108
Completed 108 108
Not Completed 0 0
Arm/Group Title Overall Study Population
Hide Arm/Group Description All randomized patients
Overall Number of Baseline Participants 220
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 220 participants
35.11
(18 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 220 participants
Female
92
  41.8%
Male
128
  58.2%
Height  
Mean (Full Range)
Unit of measure:  Centimeters
Number Analyzed 220 participants
169.58
(147 to 193)
Weight  
Mean (Full Range)
Unit of measure:  Kilograms
Number Analyzed 220 participants
72.99
(43.6 to 111.2)
1.Primary Outcome
Title Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid
Hide Description Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin
Time Frame Through 48 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 200 and 202 subjects were available for simvastatin acid AUC(0 to 48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.
Arm/Group Title MK0524B Simvastatin + MK0524A
Hide Arm/Group Description:
MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
Overall Number of Participants Analyzed 200 202
Least Squares Mean (Standard Deviation)
Unit of Measure: ng/mL * Hour
9.19  (8.38) 8.03  (7.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0524B, Simvastatin + MK0524A
Comments Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.14
Confidence Interval 90%
1.09 to 1.20
Estimation Comments [Not Specified]
2.Primary Outcome
Title Peak Plasma Concentration (Cmax) of Simvastatin Acid
Hide Description Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
Time Frame 48 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 201 and 202 subjects were available for simvastatin acid Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.
Arm/Group Title MK0524B Simvastatin + MK0524A
Hide Arm/Group Description:
MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
Overall Number of Participants Analyzed 201 202
Least Squares Mean (Standard Deviation)
Unit of Measure: ng/mL
1.016  (0.946) 0.918  (0.906)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0524B, Simvastatin + MK0524A
Comments Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.11
Confidence Interval 90%
1.05 to 1.16
Estimation Comments [Not Specified]
3.Primary Outcome
Title Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin
Hide Description Plasma Area Under the Curve of simvastatin
Time Frame Through 48 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 208 and 210 subjects were available for simvastatin AUC(0-48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.
Arm/Group Title MK0524B Simvastatin + MK0524A
Hide Arm/Group Description:
MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
Overall Number of Participants Analyzed 208 210
Least Squares Mean (Standard Deviation)
Unit of Measure: ng/mL * Hour
15.03  (9.88) 15.56  (9.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0524B, Simvastatin + MK0524A
Comments Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 0.97
Confidence Interval 90%
0.93 to 1.00
Estimation Comments [Not Specified]
4.Primary Outcome
Title Peak Plasma Concentration (Cmax) of Simvastatin
Hide Description [Not Specified]
Time Frame 48 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 209 and 210 subjects were available for simvastatin Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.
Arm/Group Title MK0524B Simvastatin + MK0524A
Hide Arm/Group Description:
MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
Overall Number of Participants Analyzed 209 210
Least Squares Mean (Standard Deviation)
Unit of Measure: ng/mL
5.81  (4.31) 6.33  (4.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0524B, Simvastatin + MK0524A
Comments Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 0.92
Confidence Interval 90%
0.87 to 0.97
Estimation Comments [Not Specified]
5.Primary Outcome
Title Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant
Hide Description Plasma Area Under the Curve of Laropiprant
Time Frame 48 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant AUC(0 to infinity) analysis for MK0524B and Simvastatin + MK0524A, respectively
Arm/Group Title MK0524B Simvastatin + MK0524A
Hide Arm/Group Description:
MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
Overall Number of Participants Analyzed 217 216
Least Squares Mean (Standard Deviation)
Unit of Measure: nmol/L * hour
5486  (2832) 5405  (2618)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0524B, Simvastatin + MK0524A
Comments Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.02
Confidence Interval 90%
0.99 to 1.04
Estimation Comments [Not Specified]
6.Primary Outcome
Title Peak Plasma Concentration (Cmax) of Laropiprant
Hide Description [Not Specified]
Time Frame 48 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively
Arm/Group Title MK0524B Simvastatin + MK0524A
Hide Arm/Group Description:
MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
Overall Number of Participants Analyzed 217 216
Least Squares Mean (Standard Deviation)
Unit of Measure: nmol/L
1030  (642) 953  (542)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0524B, Simvastatin + MK0524A
Comments Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 1.08
Confidence Interval 90%
1.02 to 1.14
Estimation Comments [Not Specified]
7.Primary Outcome
Title Peak Plasma Concentration (Cmax) of Nicotinuric Acid
Hide Description Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin
Time Frame 24 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4) and missing samples (N=1), data from a total of 215 and 216 subjects available for plasma nicotinuric acid analysis for MK0524B and Simvastatin + MK0524A, respectively.
Arm/Group Title MK0524B Simvastatin + MK0524A
Hide Arm/Group Description:
MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
Overall Number of Participants Analyzed 215 216
Least Squares Mean (Standard Deviation)
Unit of Measure: ng/mL
620  (536) 807  (469)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0524B, Simvastatin + MK0524A
Comments Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 0.77
Confidence Interval 90%
0.72 to 0.82
Estimation Comments [Not Specified]
8.Primary Outcome
Title Total Urinary Excretion of Niacin and Its Metabolites
Hide Description [Not Specified]
Time Frame 96 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 216 subjects were available for both MK0524B and Simvastatin + MK0524A for analysis of urinary excretion of nicotinuric acid and metabolites
Arm/Group Title MK0524B Simvastatin + MK0524A
Hide Arm/Group Description:
MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
Overall Number of Participants Analyzed 216 216
Least Squares Mean (Standard Deviation)
Unit of Measure: µmol
5339  (968) 5825  (1188)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK0524B, Simvastatin + MK0524A
Comments Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.
Method of Estimation Estimation Parameter Least-Squares Mean Ratio
Estimated Value 0.92
Confidence Interval 90%
0.89 to 0.94
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.
 
Arm/Group Title MK0524B Simvastatin + MK0524A
Hide Arm/Group Description MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet. Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
All-Cause Mortality
MK0524B Simvastatin + MK0524A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MK0524B Simvastatin + MK0524A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/220 (0.00%)   0/220 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MK0524B Simvastatin + MK0524A
Affected / at Risk (%) Affected / at Risk (%)
Total   61/220 (27.73%)   58/220 (26.36%) 
Cardiac disorders     
Palpitations * 1  0/220 (0.00%)  1/220 (0.45%) 
Ear and labyrinth disorders     
Ear Discomfort * 1  1/220 (0.45%)  3/220 (1.36%) 
Eye disorders     
Ocular Hyperaemia * 1  1/220 (0.45%)  0/220 (0.00%) 
Gastrointestinal disorders     
Abdominal Discomfort * 1  0/220 (0.00%)  1/220 (0.45%) 
Abdominal Pain * 1  7/220 (3.18%)  3/220 (1.36%) 
Abdominal Pain Upper * 1  2/220 (0.91%)  1/220 (0.45%) 
Aphthous Stomatitis * 1  1/220 (0.45%)  0/220 (0.00%) 
Chapped Lips * 1  0/220 (0.00%)  1/220 (0.45%) 
Constipation * 1  6/220 (2.73%)  2/220 (0.91%) 
Diarrhoea * 1  4/220 (1.82%)  2/220 (0.91%) 
Dry Mouth * 1  1/220 (0.45%)  0/220 (0.00%) 
Dyspepsia * 1  2/220 (0.91%)  3/220 (1.36%) 
Eructation * 1  0/220 (0.00%)  1/220 (0.45%) 
Nausea * 1  15/220 (6.82%)  12/220 (5.45%) 
Salivary Hypersecretion * 1  1/220 (0.45%)  0/220 (0.00%) 
Toothache * 1  0/220 (0.00%)  1/220 (0.45%) 
Vomiting * 1  3/220 (1.36%)  5/220 (2.27%) 
General disorders     
Fatigue * 1  1/220 (0.45%)  0/220 (0.00%) 
Feeling Hot * 1  3/220 (1.36%)  2/220 (0.91%) 
Feeling Jittery * 1  1/220 (0.45%)  0/220 (0.00%) 
Malaise * 1  0/220 (0.00%)  2/220 (0.91%) 
Pain * 1  1/220 (0.45%)  0/220 (0.00%) 
Infections and infestations     
Tooth Infection * 1  1/220 (0.45%)  0/220 (0.00%) 
Injury, poisoning and procedural complications     
Arthropod Bite * 1  1/220 (0.45%)  1/220 (0.45%) 
Contusion * 1  1/220 (0.45%)  0/220 (0.00%) 
Wound * 1  0/220 (0.00%)  1/220 (0.45%) 
Metabolism and nutrition disorders     
Anorexia * 1  1/220 (0.45%)  1/220 (0.45%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  4/220 (1.82%)  0/220 (0.00%) 
Pain In Extremity * 1  3/220 (1.36%)  1/220 (0.45%) 
Nervous system disorders     
Burning Sensation * 1  2/220 (0.91%)  0/220 (0.00%) 
Dizziness * 1  1/220 (0.45%)  3/220 (1.36%) 
Dysgeusia * 1  1/220 (0.45%)  0/220 (0.00%) 
Headache * 1  9/220 (4.09%)  17/220 (7.73%) 
Migraine * 1  1/220 (0.45%)  0/220 (0.00%) 
Paraesthesia * 1  4/220 (1.82%)  3/220 (1.36%) 
Somnolence * 1  1/220 (0.45%)  1/220 (0.45%) 
Syncope * 1  0/220 (0.00%)  1/220 (0.45%) 
Syncope Vasovagal * 1  1/220 (0.45%)  2/220 (0.91%) 
Psychiatric disorders     
Hypervigilance * 1  1/220 (0.45%)  0/220 (0.00%) 
Restlessness * 1  1/220 (0.45%)  0/220 (0.00%) 
Renal and urinary disorders     
Pollakiuria * 1  0/220 (0.00%)  1/220 (0.45%) 
Polyuria * 1  0/220 (0.00%)  1/220 (0.45%) 
Reproductive system and breast disorders     
Dysmenorrhoea * 1  1/220 (0.45%)  0/220 (0.00%) 
Postmenopausal Haemorrhage * 1  0/220 (0.00%)  1/220 (0.45%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/220 (0.91%)  1/220 (0.45%) 
Epistaxis * 1  1/220 (0.45%)  0/220 (0.00%) 
Pharyngolaryngeal Pain * 1  3/220 (1.36%)  1/220 (0.45%) 
Skin and subcutaneous tissue disorders     
Dermatitis * 1  0/220 (0.00%)  1/220 (0.45%) 
Dry Skin * 1  1/220 (0.45%)  0/220 (0.00%) 
Ecchymosis * 1  0/220 (0.00%)  1/220 (0.45%) 
Erythema * 1  1/220 (0.45%)  2/220 (0.91%) 
Hyperhidrosis * 1  2/220 (0.91%)  0/220 (0.00%) 
Pruritus * 1  7/220 (3.18%)  3/220 (1.36%) 
Pruritus Generalised * 1  1/220 (0.45%)  1/220 (0.45%) 
Skin Irritation * 1  1/220 (0.45%)  1/220 (0.45%) 
Swelling Face * 1  1/220 (0.45%)  0/220 (0.00%) 
Urticaria * 1  1/220 (0.45%)  0/220 (0.00%) 
Vascular disorders     
Flushing * 1  8/220 (3.64%)  17/220 (7.73%) 
Vasodilatation * 1  0/220 (0.00%)  1/220 (0.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00943124     History of Changes
Other Study ID Numbers: 0524B-070
MK0524B-070
2009_612
First Submitted: July 21, 2009
First Posted: July 22, 2009
Results First Submitted: October 9, 2009
Results First Posted: January 6, 2010
Last Update Posted: June 19, 2015