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

Bayer

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Nifedipine (Adalat, BAYA1040); Drug: Amlodipine (Norvasc); Drug: Diovan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518855

11518

Details and patient eligibility

About

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.

Enrollment: 514 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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514 participants in 2 patient groups

Arm 1

Experimental group

Description:

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

Treatment:

Drug: Diovan

Drug: Nifedipine (Adalat, BAYA1040)

Arm 2

Active Comparator group

Description:

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

Treatment:

Drug: Amlodipine (Norvasc)

Drug: Diovan