Trials Sponsors Conditions Drugs Pricing

Conditions

Hypertension Postmenopause

Keywords

Postmenopausalvasomotor symptomsessential hypertension

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (8)

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
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
+3 more secondary outcomes

Study Arms (5)

Arm 1

EXPERIMENTAL

Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Arm 3

EXPERIMENTAL

Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Arm 4

EXPERIMENTAL

Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Arm 5

PLACEBO COMPARATOR

Interventions

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

Arm 1

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

Arm 2

Eligibility Criteria

Age45 Years - 75 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Bayer
Industrylead

MeSH Terms

Conditions

HypertensionEssential Hypertension

Interventions

estradiol-drospirenone combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

Bayer Study Director
Bayer
STUDY DIRECTOR

Enrollment

750 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: FACTORIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 21, 2005

First Posted

January 24, 2005

Study Start

April 2004

Date type not reported

This date has not been verified as actual or estimated.

Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (5)

Arm 1

Arm 3

Arm 4

Arm 5

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Arm 2

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (5)

Arm 1

Arm 3

Arm 4

Arm 5

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Arm 2

Source record