High Dose BAYA1040_Nifedipine: a Long Term Combination Study

NCT ID: NCT01294215

Last Updated: 2014-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Nifedipine (Adalat, BAYA1040)

Intervention Type DRUG

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

Interventions

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Nifedipine (Adalat, BAYA1040)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Ebina, Kanagawa, Japan

Site Status

Sagamihara, Kanagawa, Japan

Site Status

Kawaguchi, Saitama, Japan

Site Status

Shinjuku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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14024

Identifier Type: -

Identifier Source: org_study_id

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