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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
750
Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Drospirenone 1 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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1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Placebo, given as tablets orally once daily in the morning for 8 weeks