PostmenopausePhase 2NCT00420342
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
A Phase 2 study testing Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) and SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) in people with Postmenopause and Hypertension, run by Bayer at 9 sites in United States.
Trial summary
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Postmenopause, Hypertension, Pre-Hypertension
- What is being tested?
- Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) and SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women 45 - 65 years old with prehypertension
Who cannot join
- Hormone therapy (estrogen/progestin)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
Arlington, Virginia, 22203
Study site
Columbia, South Carolina, 29201
Study site
Daytona Beach, Florida, 32114
Study site
Greenbrae, California, 94904
Study site
Las Vegas, Nevada, 89122
Study site
Miami, Florida, 33136
Study site
Paw Paw, Michigan, 49079
Study site
Philadelphia, Pennsylvania, 19114
Study site
San Diego, California, 92108
About this study
Official title: A Double Blind, Randomized, Active-control Study to Evaluate Effects of Drospirenone/Estradiol (Angeliq) and Medroxyprogesterone Acetate/Conjugated Equine Estrogen (Prempro) on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.
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
- Postmenopause, Hypertension, Pre-Hypertension
- Being tested
- Drospirenone/17ß-estradiol (Angeliq, BAY86-4891), SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
- Keywords
- Pre-Hypertension in Postmenopausal Women
- Medical subject headings
- Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)Drug
SH K 00641 A -Active study medication encapsulated tablet
Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)Drug
SH K 00641 B - Active study medication encapsulated tablet
SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)Drug
Active control encapsulated tablet
| Study group | Role | What they receive |
|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Experimental | 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) Receives: Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Experimental | 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) Receives: Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Active comparator | 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) Receives: Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP.
Measured: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP.
Measured: Baseline to Week 8
Secondary outcomes (10)
Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements
The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.
Measured: Baseline to Week 8
Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough
Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.
Measured: Baseline to Week 8
Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements
Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)
Measured: Baseline to Week 8
Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements
Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)
Measured: Baseline to Week 8
Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8
Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported.
Measured: 8 weeks plus 3 days
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.
Measured: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.
Measured: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.
Measured: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.
Measured: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PostmenopauseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 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
- NCT00420342
- Sponsor's protocol ID
- 91507
- Other IDs
- 310522
- Status last verified
- May 2015
- First submitted
- 9 Jan 2007
- Last updated
- 2 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Active-control Study to Evaluate Effects of Drospirenone/Estradiol (Angeliq) and Medroxyprogesterone Acetate/Conjugated Equine Estrogen (Prempro) on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
- ClinicalTrials.gov ID
- NCT00420342
- Acronym / sponsor ID
- 91507
- Conditions
- Postmenopause, Hypertension, Pre-Hypertension
- Keywords
- Pre-Hypertension in Postmenopausal Women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Posted 20 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.
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
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Experimental | Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | Experimental | Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | Active comparator | Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women 45 - 65 years old with prehypertension
Key exclusion criteria (1 listed)
- Hormone therapy (estrogen/progestin)
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 |
|---|---|---|
| Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)SH K 00641 A -Active study medication encapsulated tablet | Drug | 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) |
| Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)SH K 00641 B - Active study medication encapsulated tablet | Drug | 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) |
| SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)Active control encapsulated tablet | Drug | 1.5 mg MPA / 0.3 mg CEE (Prempro) |
Primary outcome
Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population
Time frame: Baseline to Week 8
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP.
Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population
Time frame: Baseline to Week 8
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP.
10 secondary outcomes
Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements
Time frame: Baseline to Week 8
Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8
Time frame: 8 weeks plus 3 days
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)
Time frame: Baseline to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) and SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) in people with Postmenopause and Hypertension, run by Bayer at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population (time frame: Baseline to Week 8). 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 2 Jun 2015.