Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-04-30

Brief Summary

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The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients.

To investigate incremental cost effectiveness, primary variables are mean treatment cost and achievement rate to target blood pressure level at the end of double-blind treatment period.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Adalat CR 20-40mg od + Diovan 40-80mg od

Group Type EXPERIMENTAL

Nifedipine (Adalat, BAYA1040)

Intervention Type DRUG

Diovan

Intervention Type DRUG

Arm 2

Norvasc 2.5-5mg od + Diovan 40-80mg od

Group Type ACTIVE_COMPARATOR

Amlodipine (Norvasc)

Intervention Type DRUG

Diovan

Intervention Type DRUG

Interventions

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Nifedipine (Adalat, BAYA1040)

Intervention Type DRUG

Amlodipine (Norvasc)

Intervention Type DRUG

Diovan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Untreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:

* SBP\>/=160mmHg or DBP\>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure)
* SBP\>/=150mmHg or DBP\>/=95mmHg for patients with previous treatment by antihypertensive agents

Exclusion Criteria

* Patients whose blood pressure on either day of Visit 1 or 2 is: SBP \> 200mmHg or DBP \> 120mmHg.
* Patients with secondary hypertension or hypertensive emergency such as malignant hypertension.
* Patients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study.
* Patients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study.
* Patients with uncontrolled diabetes (HbA1c \>/=8%)
* Patients with bradycardia or tachycardia (\<50 bpm, \>/=100 bpm), arrhythmia such as atrioventricular block (second and third degree), sinoatrial block or atrial fibrillation.

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No