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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Valsartan/amlodipine 80/5 mg (Drug); Valsartan 80 mg (Drug); Valsartan 160 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

Secondary outcome:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)

Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)

Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)

Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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.

Locations and Contacts

Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences, Beijing 100020, China

Beijing General Hospital of Beijing Military Region, Beijing 100700, China

Beijing Hospital, Beijing 100730, China

The First Affiliated Hospital of Medical College of Zhejiang University, Hangzhou 310007, China

The First People's Hospital of Hangzhou, Hangzhou 310006, China

The Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou 310006, China

Southeast University Affiliated Zhong Da Hospital, Nanjing 210009, China

The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China

Department of cardiology, Ruijin hospital, Shanghai 200025, China

Department of cardiology, Ruijin hospital;, Shanghai 200025, China

Fudan University affiliated zhongshan hospital, Shanghai 200032, China

Second Military Medical University Affiliated Changhai Hospital, Shanghai 200433, China

Second Military Medical University Affiliated Changzheng Hospital, Shanghai 200003, China

The First Affiliated Hospital of China Medical University, Shenyang 110001, China

The people's Hospital of Liaoning Province, Shenyang 110016, China

Second Hospital of Hebei University of Medical Sciences, Shijiazhuang 050050, China

The People's Hospital of Hebei Provincial, Shijiazhuang 050051, China

The First Affiliated Hospital of Soochow University, Suzhou 215006, China

The Second Affiliated Hospital of Soochow University, Suzhou 215004, China

Additional Information

Starting date: January 2007
Last updated: April 26, 2011

Page last updated: August 23, 2015

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