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

Phase 4

Completed

• Conditions: Stage 2 Diastolic Hypertension
• Interventions: Drug: nebivolol and lisinopril (free combination); Drug: nebivolol monotherapy; Drug: lisinopril monotherapy; Drug: placebo

• Registration Number: NCT01218100
• Lead Sponsor: Forest Laboratories

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2012-05
• Results First Submitted: 2012-05-18
• Results First Submitted QC: 2012-05-18
• Last Update Submitted: 2012-05-18
• Results First Posted: 2012-06-21
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	nebivolol and lisinopril (free combination)	Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
2	nebivolol monotherapy	Nebivolol monotherapy group - starting dose level nebivolol 5mg
3	lisinopril monotherapy	Lisinopril monotherapy group - starting dose level lisinopril 10mg
4	placebo	Placebo group - starting dose is placebo

Primary Outcome Measures

Name	Time	Method
The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.	Visit 6/(Week 0) and Visit 9/(Week 6)

Secondary Outcome Measures

Name	Time	Method
The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.	Visit 6/(Week 0) and Visit 9/(Week 6)

Trial Locations

Locations (90)

Forest Investigative Site #58; 🇺🇸 Scottsdale, Arizona, United States

Forest Investigative site 080; 🇺🇸 Tempe, Arizona, United States

Forest Investigative site 096; 🇺🇸 Tucson, Arizona, United States

Forest Investigative site 038; 🇺🇸 Buena Park, California, United States

Forest Investigative site 075; 🇺🇸 Burbank, California, United States

Forest Investigative site 042; 🇺🇸 Costa Mesa, California, United States

Forest Investigative site 028; 🇺🇸 Fountain Valley, California, United States

Forest Investigative site 064; 🇺🇸 Fresno, California, United States

Forest Investigative site 079; 🇺🇸 Lancaster, California, United States

Forest Investigative site 097; 🇺🇸 Long Beach, California, United States

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