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

Condition(s) targeted: Stage 2 Diastolic Hypertension

Intervention: nebivolol and lisinopril (free combination) (Drug); nebivolol monotherapy (Drug); lisinopril monotherapy (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Manfred Stapff, MD PhD, Study Director, Affiliation: Forest Laboratories

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).

Official title: A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.

Secondary outcome: The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

Forest Investigative site 044, Caguas 00725, Puerto Rico

Forest Investigative Site #58, Scottsdale, Arizona 85254, United States

Forest Investigative site 080, Tempe, Arizona 85282, United States

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Forest Investigative site 097, Long Beach, California 90806, United States

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Forest Investigative site 034, Charlotte, North Carolina 28204, United States

Forest Investigative site 086, Charlotte, North Carolina 28209, United States

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Starting date: October 2010
Last updated: May 18, 2012