HypertensionPhase 4NCT00123604
Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes
A Phase 4 study testing Carvedilol and Metoprolol in people with Hypertension and Type 2 Diabetes Mellitus, run by St. Paul Heart Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes Mellitus
- What is being tested?
- Carvedilol and Metoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2006
- Phase
- Phase 4
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-80 years old
- Documented history of type 2 diabetes
- Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period
- Stable anti-diabetic regimen throughout the study period
- Body mass index (BMI) between 22-45 kg/m2
- HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone
- Screening blood pressure (BP) > 130/80 (average of 3 sitting measurements), with current medications
Who cannot join
- Uncontrollable or symptomatic arrhythmias
- Unstable angina
- Sick sinus syndrome or second or third degree heart block
- Decompensated heart failure
- Myocardial infarction (MI) or stroke within 3 months of screening
- Bradycardia
Show all 17Show fewer
- Chronic obstructive pulmonary disease (COPD) with required inhaled or oral bronchodilators or corticosteroids
- Bronchial asthma or related bronchospastic conditions
- New onset/diagnosed type 2 diabetes (<3 months)
- Clinically significant renal or liver disease (creatinine >2.5 mg/dL)
- Endocrine disorders
- Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics
- Use of beta-blockers within 3 months of screening
- Use of corticosteroids
- Systemic disease, including cancer, with reduced life expectancy (<12 months)
- Psychological illness/condition that interferes with comprehension of study requirements
- Use of an investigational drug within 30 days of entry into study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Carvedilol and Metoprolol on Endothelial Function in Hypertensive Patients With Type 2 Diabetes Mellitus
The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
Read the detailed description
Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.
- Conditions
- Hypertension, Type 2 Diabetes Mellitus
- Being tested
- Carvedilol, Metoprolol
- Keywords
- beta-blockers, endothelial function
- 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
Also called Coreg
25 mg twice daily for five months.
MetoprololDrug
Also called Lopressor
200 mg twice daily for five months.
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Experimental | Carvedilol, orally, 25 mg, twice daily for five months Receives: Drug: Carvedilol |
| Metoprolol | Active comparator | Metoprolol, orally, 200 mg, twice daily for five months. Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation
Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.
Measured: change from baseline to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2006
- Study completionJun 2006
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul Heart Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Aaron S. Kelly, Ph.D., St. Paul Heart Clinic
- Investigators
- Alan J Bank, M.D., Principal investigator, St. Paul Heart Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123604
- Sponsor's protocol ID
- GSK101598
- Status last verified
- Nov 2014
- First submitted
- 21 Jul 2005
- Last updated
- 18 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bank AJ, Kelly AS, Thelen AM, Kaiser DR, Gonzalez-Campoy JM. Effects of carvedilol versus metoprolol on endothelial function and oxidative stress in patients with type 2 diabetes mellitus. Am J Hypertens. 2007 Jul;20(7):777-83. doi: 10.1016/j.amjhyper.2007.01.019.
PubMed 17586413
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carvedilol and Metoprolol on Endothelial Function in Hypertensive Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00123604
- Acronym / sponsor ID
- GSK101598
- Conditions
- Hypertension, Type 2 Diabetes Mellitus
- Keywords
- beta-blockers, endothelial function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- St. Paul Heart ClinicUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 25 Jul 2005 (estimated)
- Results
- Posted 18 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
Detailed description
Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Experimental | Drug: CarvedilolCarvedilol, orally, 25 mg, twice daily for five months |
| Metoprolol | Active comparator | Drug: MetoprololMetoprolol, orally, 200 mg, twice daily for five months. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 30-80 years old
- Documented history of type 2 diabetes
- Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period
- Stable anti-diabetic regimen throughout the study period
- Body mass index (BMI) between 22-45 kg/m2
Key exclusion criteria (17 listed)
- Uncontrollable or symptomatic arrhythmias
- Unstable angina
- Sick sinus syndrome or second or third degree heart block
- Decompensated heart failure
- Myocardial infarction (MI) or stroke within 3 months of screening
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 |
|---|---|---|
| CarvedilolAlso: Coreg25 mg twice daily for five months. | Drug | Carvedilol |
| MetoprololAlso: Lopressor200 mg twice daily for five months. | Drug | Metoprolol |
Primary outcome
Flow Mediated Dilation
Time frame: change from baseline to 5 months
Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 17586413Bank AJ, Kelly AS, Thelen AM, Kaiser DR, Gonzalez-Campoy JM. Effects of carvedilol versus metoprolol on endothelial function and oxidative stress in patients with type 2 diabetes mellitus. Am J Hypertens. 2007 Jul;20(7):777-83. doi: 10.1016/j.amjhyper.2007.01.019.
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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.
Alan J Bank, M.D. principal investigator
St. Paul Heart Clinic
1 site 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 and Type 2 Diabetes Mellitus, run by St. Paul Heart Clinic at 1 site 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 7 inclusion and 17 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 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 18 Nov 2014). 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?
Flow Mediated Dilation (time frame: change from baseline to 5 months). 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 NCT00123604, 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 18 Nov 2014.