Overview

Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP>= 100 mmHg).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Forest Laboratories
Treatments:
Lisinopril
Nebivolol
Criteria
Inclusion Criteria:

- male and female outpatients 18 to 64 years of age

- Females must be post-menopausal, or not pregnant and using an approved contraceptive
regimen

- stage 2 diastolic hypertension (DBP >= 100 mmHg)

Exclusion Criteria:

- secondary hypertension

- evidence of other concurrent disease or conditions that might interfere with the
conduct of the study

- participation in an investigational drug study within 30 days or 5 half-lives,
whichever is longer, of Screening (Visit 1).

- have a history of hypersensitivity to nebivolol or other β-blockers, or any
contraindication to β-blocker use