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

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.

This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Valsartan/amlodipine 80/5 mg; Drug: Valsartan 80 mg; Drug: Valsartan 160 mg

• Study Type: Interventional
• Enrollment (Actual): 1134
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Beijing Hospital
  • Beijing, China, 100020
    • Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences
  • Beijing, China, 100700
    • Beijing General Hospital of Beijing Military Region
  • Hangzhou, China, 310006
    • The First People's Hospital of Hangzhou
  • Hangzhou, China, 310006
    • The Second Affiliated Hospital of Medical College of Zhejiang University
  • Hangzhou, China, 310007
    • The first affiliated hospital of medical college of zhejiang university
  • Nanjing, China, 210029
    • The First Affiliated Hospital of Nanjing Medical University
  • Nanjing, China, 210009
    • Southeast University Affiliated Zhong Da Hospital
  • Shanghai, China, 200003
    • Second Military Medical University Affiliated Changzheng Hospital
  • Shanghai, China, 200025
    • Department of cardiology, Ruijin hospital;
  • Shanghai, China, 200025
    • Department of cardiology, Ruijin hospital
  • Shanghai, China, 200032
    • Fudan University Affiliated Zhongshan Hospital
  • Shanghai, China, 200433
    • Second Military Medical University Affiliated Changhai Hospital
  • Shenyang, China, 110001
    • The First Affiliated Hospital of China Medical University
  • Shenyang, China, 110016
    • The People's Hospital of Liaoning Province
  • Shijiazhuang, China, 050050
    • Second Hospital of Hebei University of Medical Sciences
  • Shijiazhuang, China, 050051
    • The People's Hospital of Hebei Provincial
  • Suzhou, China, 215006
    • The First Affiliated Hospital of Soochow University
  • Suzhou, China, 215004
    • The Second Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of 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.	Baseline to end of study (Week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of 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.	Baseline to end of study (Week 8)
Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)	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.	Baseline to end of study (Week 8)
Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)	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.	End of study (Week 8)
Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)	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.	End of study (Week 8)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): November 1, 2007
• Study Completion (ACTUAL): November 1, 2007

Study Registration Dates

• First Submitted: December 18, 2006
• First Submitted That Met QC Criteria: December 18, 2006
• First Posted (ESTIMATE): December 19, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): April 28, 2011
• Last Update Submitted That Met QC Criteria: April 26, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Hypertension, valsartan, amlodipine, high blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Valsartan
• Other Study ID Numbers: CVAA489A2316