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High Dose BAYA1040_Nifedipine: a Long Term Combination 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, Essential hypertension, Japanese Patients, Phase III, combination study, 14024

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 who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study

Exclusion Criteria:

Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
Patients with secondary hypertension or hypertensive emergency

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

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)

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

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

Safety variables

Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.

Full Information

NCT ID

NCT01294215

First Posted

February 10, 2011

Last Updated

June 20, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01294215

Brief Title

High Dose BAYA1040_Nifedipine: a Long Term Combination Study

Official Title

A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

June 2012 (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 safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.

6. Conditions and Keywords

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

Hypertension

Keywords

BAYA1040, Nifedipine, Essential hypertension, Japanese Patients, Phase III, combination study, 14024

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nifedipine (Adalat, BAYA1040)

Intervention Description

Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID)

Primary Outcome Measure Information:

Title

Efficacy changes measured by sitting diastolic blood pressure (DBP)

Time Frame

Up to 52 weeks

Secondary Outcome Measure Information:

Title

Efficacy changes measured by sitting systolic blood pressure (SBP)

Time Frame

Up to 52 weeks

Title

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

Time Frame

Up to 52 weeks

Title

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 52 weeks

Title

Safety variables

Description

Adverse events, vital signs, electrocardiography (ECG), and laboratory tests were evaluated.

Time Frame

Up to 30 days after the last dose of study drug

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 who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study Exclusion Criteria: Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg 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

Ebina

State/Province

Kanagawa

ZIP/Postal Code

243-0401

Country

Japan

City

Sagamihara

State/Province

Kanagawa

ZIP/Postal Code

252-0311

Country

Japan

City

Kawaguchi

State/Province

Saitama

ZIP/Postal Code

332-0012

Country

Japan

City

Shinjuku

State/Province

Tokyo

ZIP/Postal Code

169-0072

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

High Dose BAYA1040_Nifedipine: a Long Term Combination Study

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