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

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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

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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 011; 🇺🇸 Raleigh, North Carolina, United States

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

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

Forest Investigative Site 073; 🇺🇸 Los Angeles, California, United States

Forest Investigative Site 001; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 012; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 032; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 055; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 007; 🇺🇸 Chicago, Illinois, United States

Forest Investigative Site 023; 🇺🇸 Las Vegas, Nevada, United States

Forest Investigative Site 052; 🇺🇸 Las Vegas, Nevada, United States

Forest Investigative Site 002; 🇺🇸 Columbus, Ohio, United States

Forest Investigative Site 050; 🇺🇸 Norman, Oklahoma, United States

Forest Investigative Site 015; 🇺🇸 Houston, Texas, United States

Forest Investigative Site 026; 🇺🇸 Houston, Texas, United States

Forest Investigative Site 074; 🇺🇸 Houston, Texas, United States

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

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

Forest Investigative Site 058; 🇺🇸 New Orleans, Louisiana, United States

Forest Investigative Site 009; 🇺🇸 Atlanta, Georgia, United States

Forest Investigative Site 051; 🇺🇸 Trenton, New Jersey, United States

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

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

Forest Investigative Site 037; 🇺🇸 Dallas, Texas, United States

Forest Investigative Site 033; 🇺🇸 Ft. Lauderdale, Florida, United States

Forest Investigative Site 008; 🇺🇸 Lutherville, Maryland, United States

Forest Investigative Site 043; 🇺🇸 Haltom City, Texas, United States

Forest Investigative Site 031; 🇺🇸 St. Petersburg, Florida, United States

Forest Investigative Site 016; 🇺🇸 Raleigh, North Carolina, United States

Forest Investigative Site 045; 🇺🇸 Oviedo, Florida, United States

Forest Investigative Site 029; 🇺🇸 Louisville, Kentucky, United States

Forest Investigative Site 014; 🇺🇸 Elizabeth, New Jersey, United States

Forest Investigative Site 036; 🇺🇸 Winston-Salem, North Carolina, United States

Forest Investigative Site 063; 🇺🇸 Norfolk, Virginia, United States

Forest Investigative Site 053; 🇺🇸 Beaumont, Texas, United States

Forest Investigative Site 056; 🇺🇸 Downingtown, Pennsylvania, United States

Forest Investigative Site 048; 🇺🇸 Las Vegas, Nevada, United States

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

Forest Investigative Site 018; 🇺🇸 Spring Valley, California, United States

Forest Investigative Site 038; 🇺🇸 Belzoni, Mississippi, United States

Forest Investigative Site 019; 🇺🇸 Brooklyn Center, Minnesota, United States

Forest Investigative Site 025; 🇺🇸 Augusta, Kansas, United States

Forest Investigative Site 004; 🇺🇸 Morton, Illinois, United States

Forest Investigative Site 062; 🇺🇸 Fall River, Massachusetts, United States

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

Forest Investigative Site 060; 🇺🇸 San Bernardino, California, United States

Forest Investigative Site 077; 🇺🇸 Roseville, California, United States

Forest Investigative Site 072; 🇺🇸 Evansville, Indiana, United States

Forest Investigative Site 035; 🇺🇸 Olive Branch, Mississippi, United States

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

Forest Investigative Site 066; 🇺🇸 Boerne, Texas, United States

Forest Investigative Site 022; 🇺🇸 Pelzer, South Carolina, United States

Forest Investigative Site 027; 🇺🇸 Houston, Texas, United States

Forest Investigative Site 071; 🇺🇸 Orem, Utah, United States

Forest Investigative Site 064; 🇺🇸 Norfolk, Virginia, United States

Forest Investigative Site 046; 🇺🇸 Port Orchard, Washington, United States

Forest Investigative Site 069; 🇺🇸 Newburgh, Indiana, United States

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

Forest Investigative Site 075; 🇺🇸 Paw Paw, Michigan, United States

Forest Investigative Site 028; 🇺🇸 Denver, Colorado, United States

Forest Investigative Site 044; 🇺🇸 Longwood, Florida, United States

Forest Investigative Site 047; 🇺🇸 La Mesa, California, United States

Forest Investigative Site 059; 🇺🇸 Brooksville, Florida, United States

Forest Investigative Site 054; 🇺🇸 San Francisco, California, United States

Forest Investigative Site 061; 🇺🇸 Metairie, Louisiana, United States

Forest Investigative Site 006; 🇺🇸 Hallandale Beach, Florida, United States

Forest Investigative Site 057; 🇺🇸 New Orleans, Louisiana, United States

Forest Investigative Site 010; 🇺🇸 Charlotte, North Carolina, United States

Forest Investigative Site 068; 🇺🇸 Madisonville, Kentucky, United States

Forest Investigative Site 017; 🇺🇸 Chaska, Minnesota, United States

Forest Investigative Site 005; 🇺🇸 Wilmington, North Carolina, United States

Forest Investigative Site 003; 🇺🇸 Asheboro, North Carolina, United States

Forest Investigative Site 030; 🇺🇸 Portland, Oregon, United States

Forest Investigative Site 042; 🇺🇸 Sandy, Utah, United States

Forest Investigative Site 076; 🇺🇸 Corpus Christi, Texas, United States