Phase 2
Completed N=101
Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease
Source: ClinicalTrials.gov NCT00553969 ↗Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Dec 2014
Primary outcomePrimary: Change in Disease Score (DS) Among the Treatment Groups — -2.48; -2.29; -2.38; -0.96 Overall Rasmussen Disease Score Change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Disease Score (DS) Among the Treatment Groups |
-2.48; -2.29; -2.38; -0.96 | — |
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. Informational only — not medical advice.