Overview

The Vascular Effects of Carvedilol Controlled Release (CR) in Abdominally Obese Hypertensive Patients

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the effects of two different combination therapies for high blood pressure on vascular health.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Paul Heart Clinic
Collaborator:
GlaxoSmithKline
Treatments:
Carvedilol
Hydrochlorothiazide
Lisinopril
Criteria
Inclusion Criteria:

- >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 Criteria:

- 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