NCT00102141

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Apr 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2014

First QC Date

January 21, 2005

Last Update Submit

December 11, 2014

Conditions

HypertensionPostmenopause

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
Drug: Placebo

Arm 2

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

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
PlaceboDRUG

Placebo, given as tablets orally once daily in the morning for 8 weeks

Arm 5

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

MeSH Terms

Conditions

HypertensionEssential Hypertension

Interventions

estradiol-drospirenone combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

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 1, 2004

Study Completion

July 1, 2005

Last Updated

December 15, 2014

Record last verified: 2014-12