HypertensionPhase 3NCT00624065
Research Study To Test Carvedilol CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure
A Phase 3 study of Hypertension, run by GlaxoSmithKline at 76 sites in United States.
Trial summary
Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 76 sitesUnited States
- Study dates
- Mar 2008to Aug 2008
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18-80 years; stage 1 or 2 hypertension currently receiving 0 or 1 antihypertensive medication; mean sitting systolic blood pressure >/=140mmHg to </=170mmHg, or mean sitting diastolic blood pressure >/=90 to </=105mmHg. Subjects taking one hypertensive medication had their medication withdrawn and entered a wash-out phase prior to randomization.
Who cannot join
- Subject taking two or more antihypertensive medications, known contraindication to angiotensin-converting enzyme (ACE) inhibitors or alpha- or beta-blocker therapy, subject has Type 1 or Type 2 diabetes
Trial locations and contacts
76 sites in 1 country.
76 sites in 1 country
United States76 sites
GSK Investigational Site
Albuquerque, New Mexico, 87102
GSK Investigational Site
Altoona, Pennsylvania, 16602
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Aurora, Illinois, 60504
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Bellingham/Washington, Washington, 98226
GSK Investigational Site
Beloit, Wisconsin, 53511
GSK Investigational Site
Beuna Park, California, 90620
GSK Investigational Site
Buffalo, New York, 14209
GSK Investigational Site
Buffalo, New York, 14215
GSK Investigational Site
Butte, Montana, 59701
GSK Investigational Site
Chandler, Arizona, 77030
GSK Investigational Site
Chicago, Illinois, 60607
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Columbia, Maryland, 21045
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Columbia, South Carolina, 29204
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Corvallis, Oregon, 97330
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Draper, Utah, 84020
GSK Investigational Site
East Syracuse, New York, 13057
GSK Investigational Site
Elkhart, Indiana, 46514
GSK Investigational Site
Fargo, North Dakota, 58103
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Georgetown, Texas, 78626
GSK Investigational Site
Gig Harbor, Washington, 98335
GSK Investigational Site
Gillespie, Illinois, 62033
GSK Investigational Site
Glendale, Arizona, 85308
GSK Investigational Site
Goodyear, Arizona, 85395
GSK Investigational Site
Grand Prairie, Texas, 75052
GSK Investigational Site
Havertown, Pennsylvania, 19083
GSK Investigational Site
Hollywood, Florida, 33023
GSK Investigational Site
Houston, Texas, 77081
GSK Investigational Site
Indianapolis, Indiana, 46250
GSK Investigational Site
Indianapolis, Indiana, 46260
GSK Investigational Site
Jersey Shore, Pennsylvania, 17740
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Lansdale, Pennsylvania, 19446
GSK Investigational Site
Las Vegas, Nevada, 89016
GSK Investigational Site
Las Vegas, Nevada, 89119
GSK Investigational Site
Litchifield Park/Arizona, Arizona, 85340
GSK Investigational Site
Magna, Utah, 84044
GSK Investigational Site
Manning, South Carolina, 29102
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Mobile, Alabama, 36617
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
New York, New York, 10075
GSK Investigational Site
Olympia, Washington, 98502-8151
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Paducah, Kentucky, 42003
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Philadelphia, Pennsylvania, 19154
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Poway, California, 92064
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
San Antonio, Texas, 78224
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Ramon, California, 94583
GSK Investigational Site
Sandy City, Utah, 84094
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
Slidell, Louisiana, 70458
GSK Investigational Site
Sugar Land, Texas, 77479
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tamarac, Florida, 33321
GSK Investigational Site
Tucson, Arizona, 85745
GSK Investigational Site
Tustin, California, 92780
GSK Investigational Site
Vista, California, 92081
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
Westfield, New York, 14787
GSK Investigational Site
Wichita, Kansas, 67205
GSK Investigational Site
Wichita, Kansas, 67207
About this study
Official title: COR111096, A Randomized, Double-Blind, Active-Controlled, Parallel Group, Multicenter Study Comparing the Proportion of Subjects With Stage 1 or 2 Essential Hypertension Who Achieve Target Blood Pressure While Receiving Either Carvedilol CR + Lisinopril or Lisinopril Monotherapy
Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.
- Conditions
- Hypertension
- Being tested
- carvedilol controlled release/lisinopril, lisinopril + placebo
- Keywords
- target blood pressure, hypertension, COREG CR, carvedilol CR, Stage 1 or 2 essential hypertension, lisinopril
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carvedilol controlled release/lisinoprilDrug
carvedilol CR + lisinopril given as separate pills
lisinopril + placeboDrug
lisinopril plus placebo to match carvedilol CR
| Study group | Role | What they receive |
|---|---|---|
| carvedilol CR + lisinopril | Experimental | Not described Receives: Drug: carvedilol controlled release/lisinopril |
| lisinopril + placebo | Active comparator | Not described Receives: Drug: lisinopril + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment
Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose.
Measured: Week 6
Secondary outcomes (1)
Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6
Mean change was calculated as Week 6 values minus Baseline values.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624065
- Sponsor's protocol ID
- COR111096
- Status last verified
- Nov 2016
- First submitted
- 14 Feb 2008
- Last updated
- 28 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
GSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COR111096, A Randomized, Double-Blind, Active-Controlled, Parallel Group, Multicenter Study Comparing the Proportion of Subjects With Stage 1 or 2 Essential Hypertension Who Achieve Target Blood Pressure While Receiving Either Carvedilol CR + Lisinopril or Lisinopril Monotherapy
- ClinicalTrials.gov ID
- NCT00624065
- Acronym / sponsor ID
- COR111096
- Conditions
- Hypertension
- Keywords
- target blood pressure, hypertension, COREG CR, carvedilol CR, Stage 1 or 2 essential hypertension, lisinopril
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline. Subjects will be randomized to receive either carvedilol CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carvedilol CR + lisinopril | Experimental | Drug: carvedilol controlled release/lisinopril |
| lisinopril + placebo | Active comparator | Drug: lisinopril + placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female age 18-80 years; stage 1 or 2 hypertension currently receiving 0 or 1 antihypertensive medication; mean sitting systolic blood pressure >/=140mmHg to </=170mmHg, or mean sitting diastolic blood pressure >/=90 to </=105mmHg. Subjects taking one hypertensive medication had their medication withdrawn and entered a wash-out phase prior to randomization.
Key exclusion criteria (1 listed)
- Subject taking two or more antihypertensive medications, known contraindication to angiotensin-converting enzyme (ACE) inhibitors or alpha- or beta-blocker therapy, subject has Type 1 or Type 2 diabetes
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 |
|---|---|---|
| carvedilol controlled release/lisinoprilcarvedilol CR + lisinopril given as separate pills | Drug | carvedilol CR + lisinopril |
| lisinopril + placebolisinopril plus placebo to match carvedilol CR | Drug | lisinopril + placebo |
Primary outcome
Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment
Time frame: Week 6
Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose.
1 secondary outcome
Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundGSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
76 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hypertension, run by GlaxoSmithKline at 76 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 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 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 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?
Yes. Results are posted in the registry (first posted 3 Aug 2009). 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?
Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00624065, which also lists 1 linked publication.
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 28 Dec 2016.