Phase 2
N=101
Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease
Pre-hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00553969 ↗Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Dec 2014
Primary outcome: Primary: Change in Disease Score (DS) Among the Treatment Groups — -2.48; -2.29; -2.38; -0.96 Overall Rasmussen Disease Score Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carvedilol phosphate (Drug); lisinopril (Drug); carvedilol phosphate and lisinopril (Drug); placebo and placebo (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Disease Score (DS) Among the Treatment Groups |
-2.48; -2.29; -2.38; -0.96 | — |
Summary
This study will examine the individual and combined effects of Coreg CR and lisinopril, on cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo controlled comparison over a 9-month study period. Patients to be randomized will have pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least one additional cardiovascular risk factor.
Eligibility Criteria
Inclusion Criteria
- Males and females > 18 years old with pre-hypertensive or borderline blood pressures (systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg) deemed not to need antihypertensive therapy. Subjects must also have one additional risk factor for cardiovascular disease, including:
- LDL > 130 and 100 and < 126 mg/dL
- Body mass index ≥ 30
- Smoker
- Family history of premature heart disease or hypertension
Exclusion Criteria
- Patients with a history of cardiac, cerebral or other vascular events within the previous 6 months will be excluded. Other exclusions include background therapy with a beta blocker or ACE inhibitor therapy, known or suspected intolerance to beta blockers or ACE inhibitors, angiotensin receptor blocker therapy, or diabetes. Pregnant or lactating women, and women of child-bearing age who are not using an acceptable form of contraception are also excluded from this study.
Data sourced from ClinicalTrials.gov (NCT00553969). 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.