Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women - Full Text View

Purpose

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol cypionate Estradiol valerate Estradiol acetate Estradiol hemihydrate Drospirenone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Mean change in diastolic blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
Mean changes in 24-hour diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in daytime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in daytime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in nighttime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in nighttime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in systolic APBM at through [ Time Frame: After 8 weeks of treatment ]
Mean change in diastolic APBM at through [ Time Frame: After 8 weeks of treatment ]


Enrollment:	750
Study Start Date:	April 2004
Study Completion Date:	July 2005

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	45 Years to 75 Years (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102141

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

Additional Information:

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00102141 History of Changes
Other Study ID Numbers:	91202 306743
Study First Received:	January 21, 2005
Last Updated:	December 11, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:


Postmenopausal vasomotor symptoms essential hypertension

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Estradiol Polyestradiol phosphate Ethinyl Estradiol Estradiol 3-benzoate Estradiol 17 beta-cypionate Estradiol valerate Drospirenone and ethinyl estradiol combination Drospirenone 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

ClinicalTrials.gov processed this record on September 27, 2016