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High Dose BAYA1040_Nifedipine: a Dose-comparative Study

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Nifedipine (Adalat, BAYA1040)

About this trial

This is an interventional treatment trial for Hypertension focused on measuring BAYA1040_Nifedipine, Nifedipine, Essential hypertension, Japanese Patients, Phase III, 13176

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Efficacy changes measured by sitting diastolic blood pressure (DBP)

Secondary Outcome Measures

Efficacy changes measured by sitting systolic blood pressure (SBP)

Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines

Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP

Full Information

NCT ID

NCT01287260

First Posted

January 30, 2011

Last Updated

January 28, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01287260

Brief Title

High Dose BAYA1040_Nifedipine: a Dose-comparative Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

BAYA1040_Nifedipine, Nifedipine, Essential hypertension, Japanese Patients, Phase III, 13176

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

352 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Nifedipine (Adalat, BAYA1040)

Intervention Description

BAYA1040_Nifedipine 40mg twice daily (BID)

Intervention Type

Drug

Intervention Name(s)

Nifedipine (Adalat, BAYA1040)

Intervention Description

BAYA1040_Nifedipine 40mg once daily (OD)

Primary Outcome Measure Information:

Title

Efficacy changes measured by sitting diastolic blood pressure (DBP)

Time Frame

Up to 8 weeks

Secondary Outcome Measure Information:

Title

Efficacy changes measured by sitting systolic blood pressure (SBP)

Time Frame

Up to 8 weeks

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Hirosaki

State/Province

Aomori

ZIP/Postal Code

036-8082

Country

Japan

City

Kamagaya

State/Province

Chiba

ZIP/Postal Code

273-0100

Country

Japan

City

Asahikawa

State/Province

Hokkaido

ZIP/Postal Code

070-0061

Country

Japan

City

Asahikawa

State/Province

Hokkaido

ZIP/Postal Code

078-8214

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

003-0026

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

003-0825

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

004-0004

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

007-0841

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

062-0053

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

063-0841

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

064-0803

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

064-0807

Country

Japan

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

210-0852

Country

Japan

City

Daito

State/Province

Osaka

ZIP/Postal Code

574-0074

Country

Japan

City

Kishiwada

State/Province

Osaka

ZIP/Postal Code

596-8522

Country

Japan

City

Yao

State/Province

Osaka

ZIP/Postal Code

581-0011

Country

Japan

City

Tokorozawa

State/Province

Saitama

ZIP/Postal Code

359-1141

Country

Japan

City

Hachioji

State/Province

Tokyo

ZIP/Postal Code

192-0046

Country

Japan

City

Meguro

State/Province

Tokyo

ZIP/Postal Code

152-0031

Country

Japan

City

Minato

State/Province

Tokyo

ZIP/Postal Code

105-7390

Country

Japan

City

Minato

State/Province

Tokyo

ZIP/Postal Code

108-0075

Country

Japan

City

Shizuoka

ZIP/Postal Code

421-0193

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

23945965

Citation

Shimamoto K, Hasebe N, Ito S, Kario K, Kimura K, Dohi Y, Kawano Y, Rakugi H, Horiuchi M, Imaizumi T, Ohya Y. Nifedipine controlled-release 40 mg b.i.d. in Japanese patients with essential hypertension who responded insufficiently to nifedipine controlled-release 40 mg q.d.: a phase III, randomized, double-blind and parallel-group study. Hypertens Res. 2014 Jan;37(1):69-75. doi: 10.1038/hr.2013.80. Epub 2013 Aug 15.

Results Reference

derived

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High Dose BAYA1040_Nifedipine: a Dose-comparative Study

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