Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Valsartan/amlodipine

Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.

Group Type EXPERIMENTAL

Valsartan/Amlodipine

Intervention Type DRUG

Valsartan/Amlodipine 80/5mg single pill combination (SPC)

Nifedipine

Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg

Interventions

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Valsartan/Amlodipine

Valsartan/Amlodipine 80/5mg single pill combination (SPC)

Intervention Type DRUG

Nifedipine

Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg

Intervention Type DRUG

Other Intervention Names

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Exforge® Adalat

Eligibility Criteria

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Inclusion Criteria

* Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker)

Exclusion Criteria

* Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization.
* Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin \>8.0%)
* Patients had evidence of hepatic disease or renal impairment
* Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No