Status:
COMPLETED
The Vascular Effects of Carvedilol Controlled Release (CR) in Abdominally Obese Hypertensive Patients
Lead Sponsor:
St. Paul Heart Clinic
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Abdominal Obesity
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effects of two different combination therapies for high blood pressure on vascular health.
Detailed Description
Hydrochlorothiazide (HCTZ) has been a popular choice for the treatment of hypertension mainly due to its efficacy in lowering blood pressure, safety, and cost-effectiveness. Similarly, angiotensin con...
Eligibility Criteria
Inclusion
- \>18 years old
- Systolic blood pressure (SBP) \>130 and/or diastolic blood pressure (DBP) \>85 (or currently taking anti-hypertensive medication)
- Waist circumference \>102 cm (men) and \>88 cm (women)
- Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study
Exclusion
- Use of anti-hypertensive medications within one month of randomization (patients may be washed-out from anti-hypertensive medications)
- Unstable angina
- History of angina symptoms within 3 months of screening
- Decompensated heart failure
- History of myocardial infarction
- Stroke or coronary artery bypass graft within 3 months of screening
- Standard clinical contraindications to beta-blocker therapy
- Standard clinical contraindications to ACE-I therapy
- Women who are currently pregnant or planning to become pregnant (pregnancy testing will occur at specific intervals throughout study and women will be informed of potential risks during the consenting process; information specific to this risk will be detailed in the consent form)
- Breastfeeding women
- Clinically significant liver disease
- Creatinine \> 2.5 mg/dL
- Hepatic function greater than 3 times upper limit of normal
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00459056
Start Date
April 1 2007
End Date
May 1 2010
Last Update
December 6 2013
Active Locations (1)
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1
St. Paul Heart Clinic
Saint Paul, Minnesota, United States, 55102