check_circleStudy Completed
Hypertension, Postmenopause
Bayer Identifier:
91202
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
Trial 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.
Key Participants Requirements
Sex
FemaleAge
45 - 75 YearsTrial summary
Enrollment Goal
750Trial Dates
April 2004 - July 2005Phase
Phase 3Could I Receive a placebo
YesProducts
Angeliq (E2/DRSP, BAY86-4891)Accepts Healthy Volunteer
NoPrimary Outcome
- Mean change in systolic office blood pressure measured at throughdate_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
- Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)date_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Mean change in diastolic blood pressure measured at throughdate_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
- Mean changes in 24-hour diastolic ABPMdate_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
- Mean change in daytime systolic ABPMdate_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
- Mean change in daytime diastolic ABPMdate_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
- Mean change in nighttime systolic ABPMdate_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
- Mean change in nighttime diastolic ABPMdate_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
- Mean change in systolic APBM at throughdate_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
- Mean change in diastolic APBM at throughdate_rangeTime Frame:After 8 weeks of treatmentenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Factorial AssignmentTrial Arms
5