Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00413413
First received: December 18, 2006
Last updated: April 26, 2011
Last verified: April 2011
  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 April 23, 2014