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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Postmenopause	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); Drug: Placebo	Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	750 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg) With Placebo for a Treatment Period of 8 Weeks on Ambulatory and Office Cuff Blood Pressure in Postmenopausal Women With Stage 1 or Stage 2 Essential Hypertension
Study Start Date :	April 2004
Actual Study Completion Date :	July 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Arm 1	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Experimental: Arm 3	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
Experimental: Arm 4	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Placebo Comparator: Arm 5	Drug: Placebo; Placebo, given as tablets orally once daily in the morning for 8 weeks
Experimental: Arm 2	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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Mean change in systolic office blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
2. Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM) [ Time Frame: After 8 weeks of treatment ]

Secondary Outcome Measures :

1. Mean change in diastolic blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
2. Mean changes in 24-hour diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
3. Mean change in daytime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
4. Mean change in daytime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
5. Mean change in nighttime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
6. Mean change in nighttime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
7. Mean change in systolic APBM at through [ Time Frame: After 8 weeks of treatment ]
8. Mean change in diastolic APBM at through [ Time Frame: After 8 weeks of treatment ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	45 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Bayer

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00102141 History of Changes
Other Study ID Numbers:	91202; 306743
First Posted:	January 24, 2005
Last Update Posted:	December 15, 2014
Last Verified:	December 2014

Keywords provided by Bayer:

Postmenopausal; vasomotor symptoms; essential hypertension

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Estradiol; Polyestradiol phosphate; Ethinyl Estradiol; Drospirenone; Estradiol 3-benzoate; Estradiol 17 beta-cypionate; Estradiol valerate; Drospirenone and ethinyl estradiol combination; Estrogens	Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents