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Trial record 36 of 99 for:    AMLODIPINE AND VALSARTAN

Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

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: NCT00425373
Recruitment Status : Completed
First Posted : January 23, 2007
Results First Posted : February 4, 2011
Last Update Posted : April 29, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Essential Hypertension
Interventions Drug: Valsartan + amlodipine 40/2.5 mg
Drug: Valsartan + amlodipine 40/5 mg
Drug: Valsartan + amlodipine 80/2.5 mg
Drug: Valsartan + amlodipine 80/5 mg
Drug: Valsartan 40 mg
Drug: Valsartan 80 mg
Drug: Amlodipine 2.5 mg
Drug: Amlodipine 5 mg
Drug: Placebo
Enrollment 1474
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/2.5 mg Valsartan + Amlodipine 80/5 mg Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Amlodipine 5 mg Placebo
Hide Arm/Group Description Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily 4 tablet and 2 capsule placebos taken once daily
Period Title: Overall Study
Started 159 167 160 162 169 163 161 161 166
Completed 154 164 157 160 159 154 154 151 148
Not Completed 5 3 3 2 10 9 7 10 18
Reason Not Completed
Adverse Event             2             2             0             1             4             6             2             3             8
Lost to Follow-up             0             1             0             0             1             0             0             0             0
Protocol Violation             1             0             1             0             0             0             0             5             3
Withdrawal by Subject             2             0             2             1             4             0             2             2             2
Lack of Efficacy             0             0             0             0             1             3             3             0             5
Arm/Group Title Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/2.5 mg Valsartan + Amlodipine 80/5 mg Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Amlodipine 5 mg Placebo Total
Hide Arm/Group Description Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily 4 tablet and 2 capsule placebos taken once daily Total of all reporting groups
Overall Number of Baseline Participants 159 167 160 162 169 163 161 161 166 1468
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 167 participants 160 participants 162 participants 169 participants 163 participants 161 participants 161 participants 166 participants 1468 participants
53.9  (10.34) 52.8  (10.70) 52.8  (10.76) 54.1  (9.75) 52.9  (10.08) 52.6  (11.29) 53.2  (10.83) 54.4  (10.67) 51.5  (10.58) 53.1  (10.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 167 participants 160 participants 162 participants 169 participants 163 participants 161 participants 161 participants 166 participants 1468 participants
Female
46
  28.9%
49
  29.3%
40
  25.0%
39
  24.1%
38
  22.5%
49
  30.1%
49
  30.4%
40
  24.8%
55
  33.1%
405
  27.6%
Male
113
  71.1%
118
  70.7%
120
  75.0%
123
  75.9%
131
  77.5%
114
  69.9%
112
  69.6%
121
  75.2%
111
  66.9%
1063
  72.4%
1.Primary 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 was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
Arm/Group Title Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/2.5 mg Valsartan + Amlodipine 80/5 mg Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Amlodipine 5 mg Placebo
Hide Arm/Group Description:
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
4 tablet and 2 capsule placebos taken once daily
Overall Number of Participants Analyzed 159 167 160 162 169 163 161 161 166
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-13.5  (0.62) -16.5  (0.60) -12.6  (0.62) -17.0  (0.61) -8.5  (0.60) -8.8  (0.61) -10.3  (0.61) -13.4  (0.61) -4.8  (0.61)
2.Secondary 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 was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
Arm/Group Title Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/2.5 mg Valsartan + Amlodipine 80/5 mg Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Amlodipine 5 mg Placebo
Hide Arm/Group Description:
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
4 tablet and 2 capsule placebos taken once daily
Overall Number of Participants Analyzed 159 167 160 162 169 163 161 161 166
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-16.7  (0.88) -22.0  (0.86) -16.9  (0.88) -22.9  (0.87) -9.3  (0.85) -9.5  (0.87) -13.6  (0.87) -16.6  (0.87) -4.4  (0.86)
3.Secondary Outcome
Title Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)
Hide Description At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
Arm/Group Title Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/2.5 mg Valsartan + Amlodipine 80/5 mg Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Amlodipine 5 mg Placebo
Hide Arm/Group Description:
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
4 tablet and 2 capsule placebos taken once daily
Overall Number of Participants Analyzed 159 167 160 162 169 163 161 161 166
Measure Type: Number
Unit of Measure: Percentage of patients
77.4 88.0 80.6 86.4 52.1 47.9 62.1 74.5 36.1
4.Secondary Outcome
Title Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)
Hide Description At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
Arm/Group Title Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/2.5 mg Valsartan + Amlodipine 80/5 mg Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Amlodipine 5 mg Placebo
Hide Arm/Group Description:
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
4 tablet and 2 capsule placebos taken once daily
Overall Number of Participants Analyzed 159 167 160 162 169 163 161 161 166
Measure Type: Number
Unit of Measure: Percentage of patients
67.3 82.6 72.5 80.9 46.2 41.1 55.3 67.1 31.9
5.Secondary Outcome
Title Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)
Hide Description At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame Baseline to end of study (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.
Arm/Group Title Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/2.5 mg Valsartan + Amlodipine 80/5 mg Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Amlodipine 5 mg Placebo
Hide Arm/Group Description:
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
4 tablet and 2 capsule placebos taken once daily
Overall Number of Participants Analyzed 159 167 160 162 169 163 161 161 166
Measure Type: Number
Unit of Measure: Percentage of patients
55.3 75.4 59.4 72.2 33.1 30.1 41.0 57.1 18.7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 80/2.5 mg Amlodipine 5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/5 mg
Hide Arm/Group Description 4 tablet and 2 capsule placebos taken once daily Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily Amlodipine 2.5 mg 2 capsules plus 4 tablet placebos taken once daily Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
All-Cause Mortality
Placebo Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 80/2.5 mg Amlodipine 5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 80/2.5 mg Amlodipine 5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/166 (1.20%)   0/169 (0.00%)   0/163 (0.00%)   1/161 (0.62%)   0/159 (0.00%)   1/160 (0.63%)   0/161 (0.00%)   1/167 (0.60%)   0/162 (0.00%) 
Cardiac disorders                   
Supraventricular tachycardia  1  0/166 (0.00%)  0/169 (0.00%)  0/163 (0.00%)  1/161 (0.62%)  0/159 (0.00%)  0/160 (0.00%)  0/161 (0.00%)  0/167 (0.00%)  0/162 (0.00%) 
Eye disorders                   
Ulcerative keratitis  1  1/166 (0.60%)  0/169 (0.00%)  0/163 (0.00%)  0/161 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  0/161 (0.00%)  0/167 (0.00%)  0/162 (0.00%) 
Infections and infestations                   
Gastroenteritis  1  0/166 (0.00%)  0/169 (0.00%)  0/163 (0.00%)  0/161 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  0/161 (0.00%)  1/167 (0.60%)  0/162 (0.00%) 
Pyelonephritis acute  1  1/166 (0.60%)  0/169 (0.00%)  0/163 (0.00%)  0/161 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  0/161 (0.00%)  0/167 (0.00%)  0/162 (0.00%) 
Injury, poisoning and procedural complications                   
Compression fracture  1  0/166 (0.00%)  0/169 (0.00%)  0/163 (0.00%)  0/161 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/161 (0.00%)  0/167 (0.00%)  0/162 (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%
Placebo Valsartan 40 mg Valsartan 80 mg Amlodipine 2.5 mg Valsartan + Amlodipine 40/2.5 mg Valsartan + Amlodipine 80/2.5 mg Amlodipine 5 mg Valsartan + Amlodipine 40/5 mg Valsartan + Amlodipine 80/5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/166 (10.24%)   23/169 (13.61%)   19/163 (11.66%)   12/161 (7.45%)   17/159 (10.69%)   9/160 (5.63%)   12/161 (7.45%)   20/167 (11.98%)   14/162 (8.64%) 
Infections and infestations                   
Nasopharyngitis  1  17/166 (10.24%)  23/169 (13.61%)  19/163 (11.66%)  12/161 (7.45%)  17/159 (10.69%)  9/160 (5.63%)  12/161 (7.45%)  20/167 (11.98%)  14/162 (8.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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: Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00425373     History of Changes
Other Study ID Numbers: CVAA489A1301
First Submitted: January 22, 2007
First Posted: January 23, 2007
Results First Submitted: January 12, 2011
Results First Posted: February 4, 2011
Last Update Posted: April 29, 2011