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To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone

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ClinicalTrials.gov Identifier: NCT01070043
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : October 19, 2011
Last Update Posted : October 19, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hypertension
High Blood Pressure
Interventions Drug: Amlodipine 5mg/Valsartan 80 mg
Drug: Valsartan
Enrollment 60
Recruitment Details  
Pre-assignment Details A 4 week run-in phase preceded the randomized, double-blind treatment phase of the study. During the run-in phase, participants took valsartan 80 mg daily before a meal. Sixty participants entered the run-in phase. Those participants who met the inclusion criteria entered the randomized, double-blind treatment phase.
Arm/Group Title Run-In Valsartan 80 mg Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description During run-in period, oral valsartan 80 mg once daily for 4 weeks. During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks. In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
Period Title: Run-In Phase
Started 60 0 [1] 0 [2]
Completed 42 0 0
Not Completed 18 0 0
Reason Not Completed
Did not Meet Inclusion Criteria             18             0             0
[1]
This combination therapy arm is used only for double-blind phase.
[2]
This monotherapy (Valsartan 160 mg) treatment arm is used only for double-blind phase.
Period Title: Double-Blind Treatment
Started 0 21 21
Completed 0 21 19
Not Completed 0 0 2
Reason Not Completed
Adverse Event             0             0             2
Arm/Group Title Amlodipine 5mg/Valsartan 80 mg Valsartan 160 mg Total
Hide Arm/Group Description During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks. In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
59.50  (13.81) 55.13  (11.81) 57.31  (13.81)
[1]
Measure Description: Baseline measurements were based on safety/intent-to-treat (ITT) population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
9
  42.9%
8
  38.1%
17
  40.5%
Male
12
  57.1%
13
  61.9%
25
  59.5%
1.Primary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement
Hide Description Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.
Arm/Group Title Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 150.26  (12.91) 141.14  (12.71)
8 weeks 133.79  (14.63) 133.68  (12.73)
Change from baseline to 8 weeks -16.48  (15.53) -7.23  (11.60)
2.Primary Outcome
Title Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement
Hide Description Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.
Arm/Group Title Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 92.12  (10.84) 89.98  (9.37)
8 weeks 82.29  (8.74) 86.73  (9.10)
Change from baseline to 8 weeks -9.83  (7.66) -2.65  (6.75)
3.Secondary Outcome
Title Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours
Hide Description Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean systolic blood pressure (mSBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind phase.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.
Arm/Group Title Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 144.38  (17.39) 139.76  (13.46)
8 weeks 129.67  (14.03) 131.11  (12.39)
Change from baseline to 8 weeks -14.71  (11.64) -6.39  (12.06)
4.Secondary Outcome
Title Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase
Hide Description Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean diastolic blood pressure (mDBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.
Arm/Group Title Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 86.95  (14.14) 87.90  (9.44)
8 weeks 79.29  (10.70) 82.94  (8.42)
Change from baseline to 8 weeks -7.67  (7.43) -3.56  (7.70)
5.Secondary Outcome
Title Number of Participants With Adverse Events During Double-blind Phase
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all patients who received at least one study medication during the study period.
Arm/Group Title Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description:
During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
Overall Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Participants
Total AE 9 15
At least one AE 7 11
AE Not related to drug 9 15
Time Frame [Not Specified]
Adverse Event Reporting Description All patients who received at least one study medication during the double-blinded study period were included in the reported safety population.
 
Arm/Group Title Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Hide Arm/Group Description During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks. In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
All-Cause Mortality
Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   1/21 (4.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer † 1  0/21 (0.00%)  1/21 (4.76%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Amlodipine 5 mg/Valsartan 80 mg Valsartan 160 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   6/21 (28.57%)   8/21 (38.10%) 
Infections and infestations     
Upper respiratory tract infection † 1  2/21 (9.52%)  3/21 (14.29%) 
Nervous system disorders     
Dizziness † 1  0/21 (0.00%)  2/21 (9.52%) 
Headache † 1  2/21 (9.52%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  2/21 (9.52%)  2/21 (9.52%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 - 778- 8300
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01070043    
Other Study ID Numbers: CVAA489ATW01
First Submitted: February 6, 2010
First Posted: February 17, 2010
Results First Submitted: September 13, 2011
Results First Posted: October 19, 2011
Last Update Posted: October 19, 2011