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

Bayer

Status and phase

Completed

Phase 3

Conditions

Hypertension

Postmenopause

Treatments

Drug: Placebo

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00102141

306743

91202

Details and patient eligibility

About

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.

Full description

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.

Enrollment

750 patients

Sex

Female

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

750 participants in 5 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

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

Arm 3

Experimental group

Treatment:

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

Arm 4

Experimental group

Treatment:

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

Arm 5

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 2

Experimental group

Treatment:

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

Trial contacts and locations

0

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