HypertensionPhase 3NCT00102141
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
A Phase 3 study testing Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) in people with Hypertension and Postmenopause, run by Bayer.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Hypertension, Postmenopause
- What is being tested?
- Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg) With Placebo for a Treatment Period of 8 Weeks on Ambulatory and Office Cuff Blood Pressure in Postmenopausal Women With Stage 1 or Stage 2 Essential Hypertension
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.
Read the detailed description
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.
- Conditions
- Hypertension, Postmenopause
- Being tested
- Angeliq (Drospirenone/17ß-estradiol, BAY86-4891), Placebo
- Keywords
- Postmenopausal, vasomotor symptoms, essential hypertension
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
PlaceboDrug
Placebo, given as tablets orally once daily in the morning for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) |
| Arm 3 | Experimental | Not described Receives: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) |
| Arm 4 | Experimental | Not described Receives: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) |
| Arm 5 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 2 | Experimental | Not described Receives: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in systolic office blood pressure measured at through
Measured: After 8 weeks of treatment
Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)
Measured: After 8 weeks of treatment
Secondary outcomes (8)
Mean change in diastolic blood pressure measured at through
Measured: After 8 weeks of treatment
Mean changes in 24-hour diastolic ABPM
Measured: After 8 weeks of treatment
Mean change in daytime systolic ABPM
Measured: After 8 weeks of treatment
Mean change in daytime diastolic ABPM
Measured: After 8 weeks of treatment
Mean change in nighttime systolic ABPM
Measured: After 8 weeks of treatment
Mean change in nighttime diastolic ABPM
Measured: After 8 weeks of treatment
Mean change in systolic APBM at through
Measured: After 8 weeks of treatment
Mean change in diastolic APBM at through
Measured: After 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2005 (estimated)
- Study startApr 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102141
- Sponsor's protocol ID
- 91202
- Other IDs
- 306743
- Status last verified
- Dec 2014
- First submitted
- 21 Jan 2005
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg) With Placebo for a Treatment Period of 8 Weeks on Ambulatory and Office Cuff Blood Pressure in Postmenopausal Women With Stage 1 or Stage 2 Essential Hypertension
- ClinicalTrials.gov ID
- NCT00102141
- Acronym / sponsor ID
- 91202
- Conditions
- Hypertension, Postmenopause
- Keywords
- Postmenopausal, vasomotor symptoms, essential hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Jul 2005 (actual)
- First posted
- 24 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks | Drug | Arm 1 |
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks | Drug | Arm 2 |
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks | Drug | Arm 3 |
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks | Drug | Arm 4 |
| PlaceboPlacebo, given as tablets orally once daily in the morning for 8 weeks | Drug | Arm 5 |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) in people with Hypertension and Postmenopause, run by Bayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in systolic office blood pressure measured at through (time frame: After 8 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2014.