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| ID | Type | Description | Link |
|---|---|---|---|
| 306743 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Experimental |
| |
| Arm 5 | Placebo Comparator |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | Drug | Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in systolic office blood pressure measured at through | After 8 weeks of treatment | |
| Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM) | After 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in diastolic blood pressure measured at through | After 8 weeks of treatment | |
| Mean changes in 24-hour diastolic ABPM | After 8 weeks of treatment | |
| Mean change in daytime systolic ABPM |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | Drug | Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks |
|
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | Drug | Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks |
|
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | Drug | 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks |
|
| Placebo | Drug | Placebo, given as tablets orally once daily in the morning for 8 weeks |
|
| After 8 weeks of treatment |
| Mean change in daytime diastolic ABPM | After 8 weeks of treatment |
| Mean change in nighttime systolic ABPM | After 8 weeks of treatment |
| Mean change in nighttime diastolic ABPM | After 8 weeks of treatment |
| Mean change in systolic APBM at through | After 8 weeks of treatment |
| Mean change in diastolic APBM at through | After 8 weeks of treatment |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C488382 | estradiol-drospirenone combination |
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