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Trial record 31 of 101 for:    AMLODIPINE AND VALSARTAN

Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00699192
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : June 6, 2011
Last Update Posted : June 6, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Amlodipine 5 mg
Drug: Valsartan 80 mg
Drug: Valsartan 40 mg
Drug: Placebo
Enrollment 965
Recruitment Details 965 patients were enrolled in the study. Of these, 819 met the criteria for entry into the double-blind phase of the study where efficacy and safety were evaluated.
Pre-assignment Details  
Arm/Group Title Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Hide Arm/Group Description 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
Period Title: Overall Study
Started 275 272 272
Completed 259 260 261
Not Completed 16 12 11
Reason Not Completed
Missing             1             1             1
Adverse Event             9             4             3
Abnormal test procedure result(s)             0             0             1
Lack of Efficacy             0             0             1
Withdrawal by Subject             3             2             4
Administrative problems             1             3             1
Protocol Violation             2             2             0
Arm/Group Title Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg Total
Hide Arm/Group Description 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily Total of all reporting groups
Overall Number of Baseline Participants 275 272 272 819
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 275 participants 272 participants 272 participants 819 participants
71.8  (5.01) 71.6  (5.38) 71.4  (5.44) 71.6  (5.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 272 participants 272 participants 819 participants
Female
152
  55.3%
138
  50.7%
142
  52.2%
432
  52.7%
Male
123
  44.7%
134
  49.3%
130
  47.8%
387
  47.3%
1.Primary Outcome
Title Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
Hide Description At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the Week 8 assessments, an LOCF (last observation carried forward) approach was used.
Arm/Group Title Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
Overall Number of Participants Analyzed 272 269 268
Mean (Standard Deviation)
Unit of Measure: mmHg
-11.1  (12.68) -12.3  (13.23) -6.9  (14.00)
2.Secondary Outcome
Title Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Hide Description At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.
Arm/Group Title Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
Overall Number of Participants Analyzed 272 269 268
Mean (Standard Deviation)
Unit of Measure: mmHg
-4.2  (8.04) -5.3  (8.19) -1.7  (7.26)
3.Secondary Outcome
Title Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8
Hide Description A systolic blood pressure response was defined as a msSBP < 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.
Arm/Group Title Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
Overall Number of Participants Analyzed 272 269 268
Measure Type: Number
Unit of Measure: Percentage of patients
46.0 48.3 34.0
4.Secondary Outcome
Title Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)
Hide Description Systolic blood pressure control was defined as a msSBP < 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Time Frame End of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.
Arm/Group Title Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
Overall Number of Participants Analyzed 272 269 268
Measure Type: Number
Unit of Measure: Percentage of patients
31.3 37.5 20.5
5.Secondary Outcome
Title Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
Hide Description Overall blood pressure control was defined as a msSBP < 140 mmHg and msDBP < 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Time Frame End of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.
Arm/Group Title Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Hide Arm/Group Description:
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
Overall Number of Participants Analyzed 272 269 268
Measure Type: Number
Unit of Measure: Percentage of patients
30.9 36.4 19.0
Time Frame 8 weeks
Adverse Event Reporting Description Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
 
Arm/Group Title Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Hide Arm/Group Description 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
All-Cause Mortality
Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/274 (1.82%)   2/272 (0.74%)   1/272 (0.37%) 
Cardiac disorders       
Angina pectoris  1  1/274 (0.36%)  0/272 (0.00%)  0/272 (0.00%) 
Atrial fibrillation  1  1/274 (0.36%)  0/272 (0.00%)  0/272 (0.00%) 
Tachyarrhythmia  1  0/274 (0.00%)  0/272 (0.00%)  1/272 (0.37%) 
Eye disorders       
Ophthalmoplegia  1  0/274 (0.00%)  1/272 (0.37%)  0/272 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  1/274 (0.36%)  0/272 (0.00%)  0/272 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Gastric cancer  1  0/274 (0.00%)  1/272 (0.37%)  0/272 (0.00%) 
Lentigo maligna stage unspecified  1  1/274 (0.36%)  0/272 (0.00%)  0/272 (0.00%) 
Nervous system disorders       
Cerebrovascular accident  1  1/274 (0.36%)  0/272 (0.00%)  0/272 (0.00%) 
Vascular disorders       
Hypertensive crisis  1  1/274 (0.36%)  0/272 (0.00%)  0/272 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Amlodipine/Valsartan 5/80 mg Amlodipine/Valsartan 5/40 mg Amlodipine 5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/274 (0.00%)   0/272 (0.00%)   0/272 (0.00%) 
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: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00699192     History of Changes
Other Study ID Numbers: CVAA489A2318
First Submitted: June 9, 2008
First Posted: June 17, 2008
Results First Submitted: January 11, 2011
Results First Posted: June 6, 2011
Last Update Posted: June 6, 2011