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Trial record 13 of 100 for:    AMLODIPINE AND VALSARTAN

Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients (EXAM)

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ClinicalTrials.gov Identifier: NCT01167153
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : June 1, 2012
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Valsartan/Amlodipine
Drug: Nifedipine
Enrollment 564
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valsartan/Amlodipine Nifedipine
Hide Arm/Group Description Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Period Title: Overall Study
Started 282 282
Intention to Treat (ITT) 272 268
Completed 264 249
Not Completed 18 33
Reason Not Completed
Non-effective therapy             1             4
AE including clinical laboratory AE             2             8
Hypotension             1             0
Lost to Follow-up             7             9
Non-compliance to concomitant medication             0             2
Investigator initiation withdrawal,Other             1             1
Withdrawal consent             1             1
Subject initiation withdrawal, Other             5             8
Arm/Group Title Valsartan/Amlodipine Nifedipine Total
Hide Arm/Group Description Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 272 268 540
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 272 participants 268 participants 540 participants
53.8  (8.59) 53.1  (8.72) 53.5  (8.63)
[1]
Measure Description: demographic measures were based on intent to treat (ITT) population. One patient was missing from Nifedipine arm for Age, continuous measurement.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 268 participants 540 participants
Female
135
  49.6%
135
  50.4%
270
  50.0%
Male
137
  50.4%
133
  49.6%
270
  50.0%
1.Primary Outcome
Title Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)
Hide Description The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSSBP after baseline.
Arm/Group Title Valsartan/Amlodipine Nifedipine
Hide Arm/Group Description:
Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Overall Number of Participants Analyzed 267 265
Mean (Standard Deviation)
Unit of Measure: mm Hg
-16.8  (11.69) -10.6  (12.02)
2.Primary Outcome
Title Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)
Hide Description The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSDBP after baseline.
Arm/Group Title Valsartan/Amlodipine Nifedipine
Hide Arm/Group Description:
Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Overall Number of Participants Analyzed 267 265
Mean (Standard Deviation)
Unit of Measure: mm Hg
-8.5  (8.52) -4.8  (8.89)
3.Secondary Outcome
Title Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)
Hide Description

Effective SBP control rate was defined as proportion of subjects in whom MSSBP < 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline.

Effective DBP control rate was defined as proportion of subjects in whom MSDBP < 90 mmHg or MSDBP reduction ≥10 mmHg from baseline.

Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of effective BP control after baseline.
Arm/Group Title Valsartan/Amlodipine Nifedipine
Hide Arm/Group Description:
Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Overall Number of Participants Analyzed 267 265
Measure Type: Number
Unit of Measure: Percentage of participants
Achieving Effective SBP Control 82.40 63.40
Achieving Effective DBP Control 92.88 76.98
4.Secondary Outcome
Title Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks
Hide Description Blood Pressure (BP) target was defined as mean sitting BP<140/90 mm Hg in non-diabetic patients and<130/80 mm Hg in diabetic patients at 12 weeks.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of blood pressure control after baseline
Arm/Group Title Valsartan/Amlodipine Nifedipine
Hide Arm/Group Description:
Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Overall Number of Participants Analyzed 267 265
Measure Type: Number
Unit of Measure: Percentage of participants
79.03 57.36
5.Secondary Outcome
Title Change From Baseline in Orthostatic SBP and DBP at 12 Weeks
Hide Description The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic SBP and DBP after baseline.
Arm/Group Title Valsartan/Amlodipine Nifedipine
Hide Arm/Group Description:
Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Overall Number of Participants Analyzed 266 265
Mean (Standard Deviation)
Unit of Measure: mm Hg
Orthostatic diastolic blood pressure -7.2  (9.43) -3.3  (9.58)
Orthostatic systolic blood pressure -13.3  (13.86) -8.6  (13.98)
6.Secondary Outcome
Title Change From Baseline in Sitting Pulse at 12 Weeks
Hide Description Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of sitting pulse rate after baseline.
Arm/Group Title Valsartan/Amlodipine Nifedipine
Hide Arm/Group Description:
Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Overall Number of Participants Analyzed 267 264
Mean (Standard Deviation)
Unit of Measure: beats/min
-1.1  (8.49) 0.0  (8.22)
7.Secondary Outcome
Title Change From Baseline in Orthostatic Pulse at 12 Weeks
Hide Description Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic pulse rate after baseline.
Arm/Group Title Valsartan/Amlodipine Nifedipine
Hide Arm/Group Description:
Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Overall Number of Participants Analyzed 266 264
Mean (Standard Deviation)
Unit of Measure: beats/min
-0.6  (8.93) 0.4  (8.48)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety analysis population: all randomised subjects who administrated at least one dose of investigational drug.
 
Arm/Group Title Valsartan/Amlodipine Nifedipine
Hide Arm/Group Description Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
All-Cause Mortality
Valsartan/Amlodipine Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valsartan/Amlodipine Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/282 (0.00%)   1/282 (0.35%) 
Cardiac disorders     
Unstable Blood Pressure  1  0/282 (0.00%)  1/282 (0.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valsartan/Amlodipine Nifedipine
Affected / at Risk (%) Affected / at Risk (%)
Total   14/282 (4.96%)   32/282 (11.35%) 
Nervous system disorders     
Dizzy  1  11/282 (3.90%)  15/282 (5.32%) 
Headache  2  6/282 (2.13%)  20/282 (7.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
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.
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 or disclosure of trial results in their entirety.
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: NCT01167153     History of Changes
Other Study ID Numbers: CVAA489ACN02
First Submitted: July 20, 2010
First Posted: July 22, 2010
Results First Submitted: April 19, 2012
Results First Posted: June 1, 2012
Last Update Posted: June 1, 2012