Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

Condition(s) targeted: Hypertension

Intervention: Nebivolol (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Tatjana Lukic, MD, M. Sc., Study Director, Affiliation: Forest Laboratories

Overall contact:
Sandra Beaird, PhD, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of

therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age

with stage 1 or stage 2 essential hypertension.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension

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

Primary outcome: Diastolic Blood Pressure (DBP)

Secondary outcome:

Systolic Blood Pressure (SBP)

Adverse Event Recording

Minimum age: 18 Years. Maximum age: 54 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female outpatients, of age 18 - 54 years

- Patients diagnosed with stage 1 or stage 2 essential hypertension

- Normal physical examination findings and electrocardiogram (ECG) results or abnormal

findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

- Secondary hypertension or severe hypertension

- History of Type 1 diabetes mellitus

- A medical contraindication to discontinuing a current antihypertensive therapy

- Clinically significant respiratory disease that prohibit use of a beta blocker

Sandra Beaird, PhD, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com

Forest Investigative Site 065, Phoenix, Arizona 85014, United States; Recruiting

Forest Investigative Site 067, Phoenix, Arizona 85014, United States; Recruiting

Forest Investigative Site 070, Phoenix, Arizona 85014, United States; Recruiting

Forest Investigative Site 049, Buena Park, California 90620, United States; Recruiting

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Forest Investigative Site 041, Colorado Springs, Colorado 80907, United States; Withdrawn

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Forest Investigative Site 061, Metairie, Louisiana 70005, United States; Recruiting

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Starting date: August 2011
Last updated: November 1, 2011