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Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women

NCT ID: NCT00102141

Last Updated: 2014-12-15

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

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-07-31

Brief Summary

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The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.

Detailed Description

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This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Conditions

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Hypertension Postmenopause

Keywords

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Postmenopausal vasomotor symptoms essential hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Intervention Type DRUG

Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Arm 3

Group Type EXPERIMENTAL

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Intervention Type DRUG

Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Arm 4

Group Type EXPERIMENTAL

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Intervention Type DRUG

1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Arm 5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, given as tablets orally once daily in the morning for 8 weeks

Arm 2

Group Type EXPERIMENTAL

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Intervention Type DRUG

Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Interventions

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Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Intervention Type DRUG

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Intervention Type DRUG

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Intervention Type DRUG

Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

Intervention Type DRUG

Placebo

Placebo, given as tablets orally once daily in the morning for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:- Have hypertension- Are currently taking antihypertensive medications- Have had natural menopause at least 1 year prior to screening- Must require hormone therapy in the opinion of the investigator
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

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

Countries

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Czechia Poland Russia Ukraine United States

Other Identifiers

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306743

Identifier Type: -

Identifier Source: secondary_id

91202

Identifier Type: -

Identifier Source: org_study_id