HypertensionPhase 4NCT00060931
Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension
A Phase 4 study testing carvedilol and metoprolol in people with Hypertension, run by GlaxoSmithKline at 119 sites in United States.
Trial summary
Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- carvedilol and metoprolol
- How many people
- 501 participants
- Where
- 119 sitesUnited States
- Study dates
- Jun 2001to Apr 2004
- Phase
- Phase 4
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at screening must be insulin producing Type II diabetics (C peptide positive).
- Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure)
- Patients must be on a stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
- Patients must be on stable antidiabetic regimen (drug treated or diet alone).
- Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).
Who cannot join
- Patients using beta-blocker therapy.
Trial locations and contacts
119 sites in 1 country.
119 sites in 1 country
United States119 sites
GSK Investigational Site
Auburn, Maine, 04210
GSK Investigational Site
Augusta, Georgia, 30901
GSK Investigational Site
Ayer, Massachusetts, 01432
GSK Investigational Site
Baltimore, Maryland, 21204
GSK Investigational Site
Baltimore, Maryland, 21208
GSK Investigational Site
Bangor, Maine, 04401
GSK Investigational Site
Birmingham, Alabama, 35211
GSK Investigational Site
Birmingham, Alabama, 35294-0012
GSK Investigational Site
Birmingham, Alabama, 35294-2041
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Buffalo, New York, 14209
GSK Investigational Site
Camden, New Jersey, 08103
GSK Investigational Site
Camp Hill, Pennsylvania, 17011
GSK Investigational Site
Canton, Ohio, 44708
GSK Investigational Site
Chicago, Illinois, 60616
GSK Investigational Site
Christiansburg, Virginia, 24073
GSK Investigational Site
Cincinnati, Ohio, 45246
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Columbia, Alabama, 35051
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Columbus, Ohio, 43212
GSK Investigational Site
Connellsville, Pennsylvania, 15425
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Derby, Connecticut, 06418
GSK Investigational Site
Downington, Pennsylvania, 19335
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Falls Church, Virginia, 22044
GSK Investigational Site
Farmington, Connecticut, 06030 - 1410
GSK Investigational Site
Fayetteville, Georgia, 30214
GSK Investigational Site
Fleetwood, Pennsylvania, 19522
GSK Investigational Site
Flushing, New York, 11365
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fort Meyers, Florida, 33907
GSK Investigational Site
Fredericksburg, Virginia, 20401
GSK Investigational Site
Fulton, New York, 13069
GSK Investigational Site
Gainesville, Florida, 32605
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Gulfport, Mississippi, 39501
GSK Investigational Site
Hackensack, New Jersey, 07601
GSK Investigational Site
Hartford, Connecticut, 06106
GSK Investigational Site
Haverhill, Massachusetts, 01831-2451
GSK Investigational Site
Hickory, North Carolina, 28601
GSK Investigational Site
Hollywood, Florida, 33021
GSK Investigational Site
Hollywood, Florida, 33023
GSK Investigational Site
Inverness, Florida, 34452
GSK Investigational Site
Jackson, Tennessee, 38301
GSK Investigational Site
Jacksonville, Florida, 32205
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Kingston, New York, 12401
GSK Investigational Site
Lancaster, New York, 14043
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Lexington, Kentucky, 40508
GSK Investigational Site
Linwood, New Jersey, 08221
GSK Investigational Site
Liverpool, New York, 13088
GSK Investigational Site
Margate City, New Jersey, 08402
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Memphis, Tennessee, 38163
GSK Investigational Site
Miami, Florida, 33133
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Miami, Florida, 33176
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Morrisville, Pennsylvania, 19067
GSK Investigational Site
Nashville, Tennessee, 37212
GSK Investigational Site
New Britain, Connecticut, 06050
GSK Investigational Site
New Hyde Park, New York, 11040
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
New Orleans, Louisiana, 70121
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
New York, New York, 10028
GSK Investigational Site
New York, New York, 10032
GSK Investigational Site
Newark, Delaware, 19713
GSK Investigational Site
Newburgh, Indiana, 47630
GSK Investigational Site
Ocala, Florida, 34471
GSK Investigational Site
Ocala, Florida, 34474
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Philipsburg, Pennsylvania, 16966
GSK Investigational Site
Pittsburgh, Pennsylvania, 15206
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Richmond, Virginia, 23220
GSK Investigational Site
Richmond, Virginia, 23294
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Saint Petersberg, Florida, 33705
GSK Investigational Site
Salem, Virginia, 24153
GSK Investigational Site
Sarasota, Florida, 34239
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
Scarsdale, New York, 10583
GSK Investigational Site
Sea Girt, New Jersey, 08750
GSK Investigational Site
Springfield, Massachusetts, 01107
GSK Investigational Site
Springfield, Virginia, 22151
GSK Investigational Site
Statesville, North Carolina, 28677
GSK Investigational Site
Summerville, South Carolina, 29485
GSK Investigational Site
Syracuse, New York, 13202
GSK Investigational Site
Tamarac, Florida, 33321
GSK Investigational Site
Tampa, Florida, 33614
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
The Bronx, New York, 10467
GSK Investigational Site
Tonawanda, New York, 14150
GSK Investigational Site
Voorhees Township, New Jersey, 08043
GSK Investigational Site
Wabash, Indiana, 46992
GSK Investigational Site
Waltham, Massachusetts, 02453
GSK Investigational Site
Washington D.C., District of Columbia, 20037
GSK Investigational Site
Washington D.C., District of Columbia, 20422
GSK Investigational Site
Waterford, Michigan, 48328
GSK Investigational Site
West Evanston, Illinois, 60202
GSK Investigational Site
West Grove, Pennsylvania, 19390
GSK Investigational Site
White River Junction, Utah, 05009
GSK Investigational Site
Williamsville, New York, 14221
GSK Investigational Site
Wilmington, North Carolina, 28412
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Worcester, Massachusetts, 01605
GSK Investigational Site
Worcester, Massachusetts, 01610
GSK Investigational Site
Zanesville, Ohio, 43701
About this study
Official title: A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients With Type II Diabetes Mellitus.
Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure
- Conditions
- Hypertension
- Being tested
- carvedilol, metoprolol
- Keywords
- hypertension, beta-blockers, Type 2 diabetes
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carvedilolDrug
metoprololDrug
Also called carvedilol
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c at 5 months
Measured: 5 months
Secondary outcomes (1)
Blood pressure at 3 and 5 months Body weight at 3 and 5 months Lab levels (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2003 (estimated)
- Study startJun 2001
- Primary completionApr 2004
- Study completionApr 2004
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 501 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
- NCT00060931
- Sponsor's protocol ID
- 105517/347
- Status last verified
- Apr 2015
- First submitted
- 15 May 2003
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients With Type II Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00060931
- Acronym / sponsor ID
- 105517/347
- Conditions
- Hypertension
- Keywords
- hypertension, beta-blockers, Type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 16 May 2003 (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.
Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients at screening must be insulin producing Type II diabetics (C peptide positive).
- Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure)
- Patients must be on a stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
- Patients must be on stable antidiabetic regimen (drug treated or diet alone).
- Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).
Key exclusion criteria (1 listed)
- Patients using beta-blocker therapy.
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 | Drug | – |
| metoprololAlso: carvedilol | Drug | – |
Primary outcome
Change from baseline in HbA1c at 5 months
Time frame: 5 months
1 secondary outcome
Blood pressure at 3 and 5 months Body weight at 3 and 5 months Lab levels (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months.
Time frame: 5 months
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 14 Apr 2015.
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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
119 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carvedilol and metoprolol in people with Hypertension, run by GlaxoSmithKline at 119 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 5 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline in HbA1c at 5 months (time frame: 5 months). 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 14 Apr 2015.