High Dose BAYA1040_Nifedipine: a Dose-comparative Study

January 28, 2014 updated by: Bayer

A Multicenter, Double-blind, Parallel-group Comparative Study Between Oral BAYA1040_CR 80 mg and 40 mg for 8 Weeks in Patients With Essential Hypertension for Whom Oral BAYA1040_CR 40 mg is Insufficient

This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 3

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
      • Shizuoka, Japan, 421-0193
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8082
    • Chiba
      • Kamagaya, Chiba, Japan, 273-0100
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8214
      • Asahikawa, Hokkaido, Japan, 070-0061
      • Sapporo, Hokkaido, Japan, 064-0807
      • Sapporo, Hokkaido, Japan, 007-0841
      • Sapporo, Hokkaido, Japan, 003-0026
      • Sapporo, Hokkaido, Japan, 003-0825
      • Sapporo, Hokkaido, Japan, 004-0004
      • Sapporo, Hokkaido, Japan, 062-0053
      • Sapporo, Hokkaido, Japan, 063-0841
      • Sapporo, Hokkaido, Japan, 064-0803
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 210-0852
    • Osaka
      • Daito, Osaka, Japan, 574-0074
      • Kishiwada, Osaka, Japan, 596-8522
      • Yao, Osaka, Japan, 581-0011
    • Saitama
      • Tokorozawa, Saitama, Japan, 359-1141
    • Tokyo
      • Hachioji, Tokyo, Japan, 192-0046
      • Meguro, Tokyo, Japan, 152-0031
      • Minato, Tokyo, Japan, 105-7390
      • Minato, Tokyo, Japan, 108-0075

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20 years or older
  • Japanese male or female
  • Outpatient with essential hypertension
  • Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug

Exclusion Criteria:

  • Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more
  • Patients with secondary hypertension or hypertensive emergency

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 2
Drug: Nifedipine (Adalat, BAYA1040)
BAYA1040_Nifedipine 40mg twice daily (BID)
Drug: Nifedipine (Adalat, BAYA1040)
BAYA1040_Nifedipine 40mg once daily (OD)
EXPERIMENTAL: Arm1
Drug: Nifedipine (Adalat, BAYA1040)
BAYA1040_Nifedipine 40mg twice daily (BID)
Drug: Nifedipine (Adalat, BAYA1040)
BAYA1040_Nifedipine 40mg once daily (OD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy changes measured by sitting diastolic blood pressure (DBP)
Time Frame: Up to 8 weeks
Up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy changes measured by sitting systolic blood pressure (SBP)
Time Frame: Up to 8 weeks
Up to 8 weeks
Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Time Frame: Up to 8 weeks
Up to 8 weeks
Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Time Frame: Up to 8 weeks
Up to 8 weeks

Collaborators and Investigators

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

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

January 30, 2011

First Submitted That Met QC Criteria

January 30, 2011

First Posted (ESTIMATE)

February 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13176

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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