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