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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Nebivolol; Drug: Placebo

• Registration Number: NCT01415531
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Status Verified: 2013-03
• Results First Submitted: 2013-03-18
• Results First Submitted QC: 2013-03-18
• Last Update Submitted: 2013-03-18
• Results First Posted: 2013-05-16
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 641

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nebivolol	Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
2	Placebo	Dose-matched placebo

Primary Outcome Measures

Name	Time	Method
Trough Seated Diastolic Blood Pressure (DBP)	Change from Baseline to Week 8	Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.

Secondary Outcome Measures

Name	Time	Method
Trough Seated Systolic Blood Pressure (SBP)	Change from Baseline to Week 8	Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.

Trial Locations

Locations (75)

Forest Investigative Site 065; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 067; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 070; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 049; 🇺🇸 Buena Park, California, United States

Forest Investigative Site 034; 🇺🇸 Burbank, California, United States

Forest Investigative Site 039; 🇺🇸 Costa Mesa, California, United States

Forest Investigative Site 024; 🇺🇸 Fountain Valley, California, United States

Forest Investigative Site 020; 🇺🇸 Fresno, California, United States

Forest Investigative Site 021; 🇺🇸 Fresno, California, United States

Forest Investigative Site 040; 🇺🇸 Greenbrae, California, United States

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