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High Dose BAYA1040 CR: a Long Term Extension Study

NCT ID: NCT01355367

Last Updated: 2014-01-29

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-04-30

Brief Summary

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This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.

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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

BAYA1040 CR 40mg BID

Interventions

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Nifedipine (Adalat, BAYA1040)

BAYA1040 CR 40mg BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable

Exclusion Criteria

* Patients with expected difficulties for the continuous 1 year follow up
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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Hirosaki, Aomori, Japan

Site Status

Kamagaya, Chiba, Japan

Site Status

Asahikawa, Hokkaido, Japan

Site Status

Asahikawa, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Kawasaki, Kanagawa, Japan

Site Status

Daitō, Osaka, Japan

Site Status

Kishiwada, Osaka, Japan

Site Status

Yao, Osaka, Japan

Site Status

Tokorozawa, Saitama, Japan

Site Status

Shizuoka, Shizuoka, Japan

Site Status

Hachiōji, Tokyo, Japan

Site Status

Meguro City, Tokyo, Japan

Site Status

Minato, Tokyo, Japan

Site Status

Minato, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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14023

Identifier Type: -

Identifier Source: org_study_id

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