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Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

NCT ID: NCT00420342

Last Updated: 2015-06-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-09-30

Brief Summary

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The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.

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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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Postmenopause Hypertension Pre-Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)

0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

SH K 00641 A -Active study medication encapsulated tablet

2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)

2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

SH K 00641 B - Active study medication encapsulated tablet

1.5 mg MPA / 0.3 mg CEE (Prempro)

1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)

Group Type ACTIVE_COMPARATOR

SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)

Intervention Type DRUG

Active control encapsulated tablet

Interventions

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

SH K 00641 A -Active study medication encapsulated tablet

Intervention Type DRUG

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

SH K 00641 B - Active study medication encapsulated tablet

Intervention Type DRUG

SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)

Active control encapsulated tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Postmenopausal women 45 - 65 years old with prehypertension

Exclusion Criteria

\- Hormone therapy (estrogen/progestin)
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 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

Locations

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Greenbrae, California, United States

Site Status

San Diego, California, United States

Site Status

Daytona Beach, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Paw Paw, Michigan, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Columbia, South Carolina, United States

Site Status

Arlington, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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310522

Identifier Type: OTHER

Identifier Source: secondary_id

91507

Identifier Type: -

Identifier Source: org_study_id

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