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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00102141 |
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: drospirenone/17ß-estradiol (Angeliq) Drug: drospirenone/17B-estradiol (Angeliq) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 1879 |
Study Start Date: | April 2004 |
Study Completion Date: | August 2005 |
Arms | Assigned Interventions |
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Arm 2: Experimental
N/A
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Drug: drospirenone/17B-estradiol (Angeliq)
Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
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Arm 1: Experimental
N/A
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Drug: drospirenone/17ß-estradiol (Angeliq)
Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
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Arm 3: Experimental
N/A
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Drug: drospirenone/17B-estradiol (Angeliq)
Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
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Arm 4: Experimental
N/A
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Drug: drospirenone/17B-estradiol (Angeliq)
1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
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Arm 5: Placebo Comparator
N/A
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Drug: Placebo
Placebo, given as tablets orally once daily in the morning for 8 weeks
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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.
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Responsible Party: | ( Bayer Healthcare Pharmaceuticals Inc., Therapeutic Area Head ) |
Study ID Numbers: | 91202, 306743 |
Study First Received: | January 21, 2005 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00102141 |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
postmenopausal moderate to severe vasomotor symptoms Stage 1 or Stage 2 essential hypertension |
Benzoates Estradiol 3-benzoate Estradiol valerate Drospirenone Vascular Diseases |
Essential hypertension Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol Hypertension |
Estrogens Aldosterone Antagonists Contraceptive Agents Hormone Antagonists Therapeutic Uses Physiological Effects of Drugs |
Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Reproductive Control Agents Hormones Pharmacologic Actions |