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

Bayer514 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

514

Conditions

Hypertension

Interventions

Nifedipine (Adalat, BAYA1040)DRUG

Amlodipine (Norvasc)DRUG

DiovanDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (4)

Unnamed facility

Hiroshima, Hiroshima, Japan

Unnamed facility

Sapporo, Hokkaido, Japan

Unnamed facility

Setagaya-ku, Tokyo, Japan

Unnamed facility

Shinjuku-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Mean treatment cost* for 16-week of double-blind treatment period

\* Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores.

Time frame: 16 weeks

Proportion of participants** achieving target blood pressure at the end of double-blind treatment period

\*\*For subjects aged under 60 years: SBP\<130mmHg and DBP\<85mmHg, for subjects aged 60 years or over: SBP\<140mmHg and DBP\<90mmHg (SBP Systolic blood pressure, DBP Diastolic blood pressure)

Time frame: at week 16

Secondary Outcomes

Treatment cost per subject to achieve the target blood pressure (Total costs for the double-blind treatment period / Number of patients who achieve the target blood pressure at the end of double-blind treatment period)

Time frame: 16 weeks

The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .

Time frame: baseline to week 16

Proportion of participants for each age group to target blood pressure level

Time frame: at week 16

Incidence of treatment-emergent drug-related adverse events

Time frame: 16 weeks

Safety variables will be summarized using descriptive statistics based on adverse events collections

Time frame: 16 weeks

Data from ClinicalTrials.gov

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