Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
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ClinicalTrials.gov Identifier: NCT00102141 |
Recruitment Status :
Completed
First Posted : January 24, 2005
Last Update Posted : December 15, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Postmenopause | Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drug: Placebo | Phase 3 |
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 |

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 |
- 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 ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102141
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT00102141 |
Other Study ID Numbers: |
91202 306743 |
First Posted: | January 24, 2005 Key Record Dates |
Last Update Posted: | December 15, 2014 |
Last Verified: | December 2014 |
Postmenopausal vasomotor symptoms essential hypertension |
Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases Drospirenone Estradiol 17 beta-cypionate Estradiol 3-benzoate Ethinyl Estradiol Drospirenone and ethinyl estradiol combination Estradiol Polyestradiol phosphate Estrogens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Mineralocorticoid Receptor Antagonists Hormone Antagonists Diuretics, Potassium Sparing Diuretics Natriuretic Agents Contraceptives, Oral, Hormonal Contraceptives, Oral |