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

January 24, 2012 updated by: Bayer

Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

514

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 733-0011
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0003
    • Tokyo
      • Setagaya-ku, Tokyo, Japan, 158-0097
      • Shinjuku-ku, Tokyo, Japan, 163-6003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Adalat CR 20-40mg od + Diovan 40-80mg od
Drug: Nifedipine (Adalat, BAYA1040)
Drug: Diovan
Active Comparator: Arm 2
Norvasc 2.5-5mg od + Diovan 40-80mg od
Drug: Diovan
Drug: Amlodipine (Norvasc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean treatment cost* for 16-week of double-blind treatment period
Time Frame: 16 weeks
* Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores.
16 weeks
Proportion of participants** achieving target blood pressure at the end of double-blind treatment period
Time Frame: at week 16
**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)
at week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
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
16 weeks
The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .
Time Frame: baseline to week 16
baseline to week 16
Proportion of participants for each age group to target blood pressure level
Time Frame: at week 16
at week 16
Incidence of treatment-emergent drug-related adverse events
Time Frame: 16 weeks
16 weeks
Safety variables will be summarized using descriptive statistics based on adverse events collections
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2012

Last Update Submitted That Met QC Criteria

January 24, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11518

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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