Phase 3 N=25 Randomized Quadruple-blind Treatment

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

Abdominal Obesity · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00459056 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcome: Primary: Change in Reactive Hyperemic Index by Period (Carvedilol CR + Lisinopril vs. Lisinopril + HCTZ) — -0.26; -0.14 Ratio

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Carvedilol CR + Lisinopril (Drug); Lisinopril + HCTZ (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: St. Paul Heart Clinic
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Reactive Hyperemic Index by Period (Carvedilol CR + Lisinopril vs. Lisinopril + HCTZ)	-0.26; -0.14	—

Summary

The purpose of this study is to compare the effects of two different combination therapies for high blood pressure on vascular health.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00459056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.