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:

MedlinePlus related topics: High Blood Pressure

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
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:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

Click here to find results for studies related to Bayer Healthcare products. This link exits the ClinicalTrials.gov site

No publications provided


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

ClinicalTrials.gov processed this record on March 01, 2015