Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00413413
First received: December 18, 2006
Last updated: April 26, 2011
Last verified: April 2011
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Purpose
This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Valsartan/amlodipine 80/5 mg Drug: Valsartan 80 mg Drug: Valsartan 160 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controled, Parallel Study, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Valsartan 80 mg and Valsartan 160 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80 mg Monotherapy. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Secondary Outcome Measures:
- Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
- Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8) [ Time Frame: Baseline to end of study (Week 8) ] [ Designated as safety issue: No ]A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
- Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8) [ Time Frame: End of study (Week 8) ] [ Designated as safety issue: No ]Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
- Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8) [ Time Frame: End of study (Week 8) ] [ Designated as safety issue: No ]Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
| Enrollment: | 1134 |
| Study Start Date: | January 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Valsartan/amlodipine 80/5 mg |
Drug: Valsartan/amlodipine 80/5 mg
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
|
| Active Comparator: Valsartan 80 mg |
Drug: Valsartan 80 mg
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
| Active Comparator: Valsartan 160 mg |
Drug: Valsartan 160 mg
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female outpatients >= 18 years and < 86 years
- Patients with essential diastolic hypertension
- At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and < 10 mmHg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmHg
- At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg and < 100 mmHg
- At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg and < 110 mmHg
Exclusion Criteria:
- Severe hypertension >= 180/110 mmHg
- Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
- Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2
- History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
- Malignant hypertension
- All patients with Type I diabetes and those patients with Type 2 diabetes who are not well controlled based on the investigator's clinical judgment
- Pregnant or nursing women
- History of heart failure
- Angina pectoris
- Second or third degree heart block
- Life threatening or symptomatic arrhythmias
- Clinically significant valvular heart disease
- Evidence of a secondary form of hypertension
- Known or moderate malignant retinopathy
- Evidence of hepatic disease
- Evidence of renal impairment
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413413
Locations
| China | |
| Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences | |
| Beijing, China, 100020 | |
| Beijing General Hospital of Beijing Military Region | |
| Beijing, China, 100700 | |
| Beijing Hospital | |
| Beijing, China, 100730 | |
| The First Affiliated Hospital of Medical College of Zhejiang University | |
| Hangzhou, China, 310007 | |
| The Second Affiliated Hospital of Medical College of Zhejiang University | |
| Hangzhou, China, 310006 | |
| The First People's Hospital of Hangzhou | |
| Hangzhou, China, 310006 | |
| Southeast University Affiliated Zhong Da Hospital | |
| Nanjing, China, 210009 | |
| The First Affiliated Hospital of Nanjing Medical University | |
| Nanjing, China, 210029 | |
| Second Military Medical University Affiliated Changzheng Hospital | |
| Shanghai, China, 200003 | |
| Second Military Medical University Affiliated Changhai Hospital | |
| Shanghai, China, 200433 | |
| Fudan University affiliated zhongshan hospital | |
| Shanghai, China, 200032 | |
| Department of cardiology, Ruijin hospital | |
| Shanghai, China, 200025 | |
| Department of cardiology, Ruijin hospital; | |
| Shanghai, China, 200025 | |
| The First Affiliated Hospital of China Medical University | |
| Shenyang, China, 110001 | |
| The people's Hospital of Liaoning Province | |
| Shenyang, China, 110016 | |
| The People's Hospital of Hebei Provincial | |
| Shijiazhuang, China, 050051 | |
| Second Hospital of Hebei University of Medical Sciences | |
| Shijiazhuang, China, 050050 | |
| The First Affiliated Hospital of Soochow University | |
| Suzhou, China, 215006 | |
| The Second Affiliated Hospital of Soochow University | |
| Suzhou, China, 215004 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00413413 History of Changes |
| Other Study ID Numbers: | CVAA489A2316 |
| Study First Received: | December 18, 2006 |
| Results First Received: | August 6, 2009 |
| Last Updated: | April 26, 2011 |
| Health Authority: | China: Food and Drug Administration United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Hypertension, valsartan, amlodipine, high blood pressure |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013