HypertensionPhase 4NCT00669279
Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure
A Phase 4 study testing Carvedilol CR and Atenolol in people with Hypertension, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether atenolol or controlled release carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure measured in the aorta, a large blood vessel carrying blood away from the heart, may be a better measure of the harmful effects of high blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Carvedilol CR and Atenolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Hypertension (untreated or treated with no more then one anti-hypertensive drug)
Who cannot join
- Secondary forms of hypertension (including sleep apnea)
- Patients currently treated with two or more antihypertensive drugs
- Patients taking antihypertensive drugs with properly measured clinic systolic blood pressure greater then 170mmHg
- Isolated systolic hypertension
- Other diseases requiring treatment with blood pressure lowering medications
- Heart rate less then 55 beats/min (in the absence of beta-blocker therapy)
Show all 13Show fewer
- Known cardiovascular disease including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and TIA)
- Known diabetes mellitus (Type 1 or 2)
- Renal insufficiency defined as a serum creatinine greater then 1.5mg/dL in males and 1.4mg/dL in females
- Primary renal disease
- Pregnancy or lactation
- History of Raynaud's syndrome
- Alcoholism and recreational drug use (due to compliance concerns)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Determination of Central Aortic Blood Pressure in Hypertensive Patients Treated With Controlled-Release Carvedilol or Atenolol
The purpose of this research study is to determine whether atenolol or controlled release carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure measured in the aorta, a large blood vessel carrying blood away from the heart, may be a better measure of the harmful effects of high blood pressure on the body's organs. In the past, blood pressure has only been measured in the arms. However, blood pressure in the arms may not accurately reflect the blood pressure in the aorta and thus may mislead doctors treating high blood pressure. For this reason, we are testing whether two different medications for blood pressure, both in a class called beta blockers, have similar effects on blood pressure in the arm and aorta.
Read the detailed description
Carvedilol reduces aortic wave reflection and improves left ventricular/vascular coupling: a comparison with atenolol (CENTRAL Study) is a prospective, open-label, comparative, randomized control trial that evaluated brachial and central hemodynamic profiles in patients taking atenolol or controlled-release carvedilol.
- Conditions
- Hypertension
- Being tested
- Carvedilol CR, Atenolol
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol CRDrug
Also called Coreg CR
Dose titration of 20mg by mouth once daily for 1 week, then 40mg by mouth once daily for 1 week, then 80mg by mouth once daily for 2 weeks
AtenololDrug
Also called Tenormin
Dose titration of 25mg by mouth once daily for 1 week, then 50mg by mouth once daily for 1 week, then 100mg by mouth once daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol CR | Experimental | Not described Receives: Drug: Carvedilol CR |
| Atenolol | Experimental | Not described Receives: Drug: Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Aortic Blood Pressure
Measured: Measured at baseline and 4 weeks.
Secondary outcomes (1)
Peripheral Blood Pressure
Measured: Measured at baseline, 2 weeks, and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2010
- Study completionJul 2010
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 HypertensionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Benjamin Epstein, Pharm.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669279
- Sponsor's protocol ID
- 8COG11059
- Status last verified
- Sep 2017
- First submitted
- 28 Apr 2008
- Last updated
- 5 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Determination of Central Aortic Blood Pressure in Hypertensive Patients Treated With Controlled-Release Carvedilol or Atenolol
- ClinicalTrials.gov ID
- NCT00669279
- Acronym / sponsor ID
- 8COG11059
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Apr 2008 (estimated)
- Results
- Posted 23 Mar 2012
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 research study is to determine whether atenolol or controlled release carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure measured in the aorta, a large blood vessel carrying blood away from the heart, may be a better measure of the harmful effects of high blood pressure on the body's organs. In the past, blood pressure has only been measured in the arms. However, blood pressure in the arms may not accurately reflect the blood pressure in the aorta and thus may mislead doctors treating high blood pressure. For this reason, we are testing whether two different medications for blood pressure, both in a class called beta blockers, have similar effects on blood pressure in the arm and aorta.
Detailed description
Carvedilol reduces aortic wave reflection and improves left ventricular/vascular coupling: a comparison with atenolol (CENTRAL Study) is a prospective, open-label, comparative, randomized control trial that evaluated brachial and central hemodynamic profiles in patients taking atenolol or controlled-release carvedilol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol CR | Experimental | Drug: Carvedilol CR |
| Atenolol | Experimental | Drug: Atenolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Hypertension (untreated or treated with no more then one anti-hypertensive drug)
Key exclusion criteria (13 listed)
- Secondary forms of hypertension (including sleep apnea)
- Patients currently treated with two or more antihypertensive drugs
- Patients taking antihypertensive drugs with properly measured clinic systolic blood pressure greater then 170mmHg
- Isolated systolic hypertension
- Other diseases requiring treatment with blood pressure lowering medications
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 CRAlso: Coreg CRDose titration of 20mg by mouth once daily for 1 week, then 40mg by mouth once daily for 1 week, then 80mg by mouth once daily for 2 weeks | Drug | Carvedilol CR |
| AtenololAlso: TenorminDose titration of 25mg by mouth once daily for 1 week, then 50mg by mouth once daily for 1 week, then 100mg by mouth once daily for 2 weeks | Drug | Atenolol |
Primary outcome
Central Aortic Blood Pressure
Time frame: Measured at baseline and 4 weeks.
1 secondary outcome
Peripheral Blood Pressure
Time frame: Measured at baseline, 2 weeks, and 4 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- 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.
Benjamin Epstein, Pharm.D. principal investigator
University of Florida
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 CR and Atenolol in people with Hypertension, run by University of Florida 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 2 inclusion and 13 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 5 Oct 2017. 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 23 Mar 2012). 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?
Central Aortic Blood Pressure (time frame: Measured at baseline and 4 weeks.). 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 5 Oct 2017.