Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

Phase 4

Completed

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

• Registration Number: NCT00734630
• Lead Sponsor: Forest Laboratories

Brief Summary

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Status Verified: 2011-03
• Results First Submitted: 2011-03-31
• Results First Submitted QC: 2011-03-31
• Last Update Submitted: 2011-03-31
• Results First Posted: 2011-04-26
• Last Update Posted: 2011-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

Inclusion Criteria

• Male or female, ambulatory outpatients 18-85 years old at screening
• Have a history of hypertension
• Qualifying laboratory results

Exclusion Criteria

• Severe hypertension, including chronic kidney disease
• Documented congestive heart failure
• Have clinically significant respiratory, liver, or heart disease
• History of stroke, heart attack, or heart surgery in the last 6 months
• Have a history of hypersensitivity to nebivolol or other beta blockers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo tablets, oral administration
Nebivolol	nebivolol	Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration

Primary Outcome Measures

Name	Time	Method
Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12	From baseline Visit 5 (Week 0) to Visit 10 (Week 12)	Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).

Secondary Outcome Measures

Name	Time	Method
Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12	From baseline Visit 5 (Week 0) to Visit 10 (Week 12)	Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).

Trial Locations

Locations (75)

Forest Investigative Site 070; 🇺🇸 Gulf Shores, Alabama, United States

Forest Investigative Site 092; 🇺🇸 Huntsville, Alabama, United States

Forest Investigative Site 058; 🇺🇸 Mesa, Arizona, United States

Forest Investigative Site 059; 🇺🇸 Tempe, Arizona, United States

Forest Investigative Site 024; 🇺🇸 Anaheim, California, United States

Forest Investigative Site 012; 🇺🇸 Bell Gardens, California, United States

Forest Investigative Site 026; 🇺🇸 Chino, California, United States

Forest Investigative Site 083; 🇺🇸 Costa Mesa, California, United States

Forest Investigative Site 030; 🇺🇸 Los Angeles, California, United States

Forest Investigative Site 053; 🇺🇸 Orange, California, United States

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