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

NCT ID: NCT01218100

Last Updated: 2012-06-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

664 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Stage 2 Diastolic Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Combination group - starting dose level nebivolol 5mg and lisinopril 10mg

Group Type EXPERIMENTAL

nebivolol and lisinopril (free combination)

Intervention Type DRUG

nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks

nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks

nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks

2

Nebivolol monotherapy group - starting dose level nebivolol 5mg

Group Type ACTIVE_COMPARATOR

nebivolol monotherapy

Intervention Type DRUG

nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only)

nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks

3

Lisinopril monotherapy group - starting dose level lisinopril 10mg

Group Type ACTIVE_COMPARATOR

lisinopril monotherapy

Intervention Type DRUG

lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks

4

Placebo group - starting dose is placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks

Interventions

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nebivolol and lisinopril (free combination)

nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks

nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks

nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks

Intervention Type DRUG

nebivolol monotherapy

nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only)

nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks

Intervention Type DRUG

lisinopril monotherapy

lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks

Intervention Type DRUG

placebo

Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manfred Stapff, MD PhD

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site #58

Scottsdale, Arizona, United States

Site Status

Forest Investigative site 080

Tempe, Arizona, United States

Site Status

Forest Investigative site 096

Tucson, Arizona, United States

Site Status

Forest Investigative site 038

Buena Park, California, United States

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Forest Investigative site 075

Burbank, California, United States

Site Status

Forest Investigative site 042

Costa Mesa, California, United States

Site Status

Forest Investigative site 028

Fountain Valley, California, United States

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Forest Investigative site 064

Fresno, California, United States

Site Status

Forest Investigative site 079

Lancaster, California, United States

Site Status

Forest Investigative site 097

Long Beach, California, United States

Site Status

Forest Investigative site 049

Los Angeles, California, United States

Site Status

Forest Investigative site 081

Riverside, California, United States

Site Status

Forest Investigative site 040

San Marino, California, United States

Site Status

Forest Investigative site 059

San Ramon, California, United States

Site Status

Forest Investigative site 074

Santa Ana, California, United States

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Forest Investigative site 072

Tustin, California, United States

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Forest Investigative site 077

Colorado Springs, Colorado, United States

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Forest Investigative site 050

Waterbury, Connecticut, United States

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Forest Investigative site 019

Boca Raton, Florida, United States

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Forest Investigative site 056

Brandon, Florida, United States

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Forest Investigative site 043

Brooksville, Florida, United States

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Forest Investigative site 035

Fort Lauderdale, Florida, United States

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Forest Investigative site 002

Hialeah, Florida, United States

Site Status

Forest Investigative site 003

Miami, Florida, United States

Site Status

Forest Investigative site 067

Miami, Florida, United States

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Forest Investigative site 057

Miami, Florida, United States

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Forest Investigative site 068

Miami, Florida, United States

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Forest Investigative site 007

Miami, Florida, United States

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Forest Investigative site 009

New Port Richey, Florida, United States

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Forest Investigative site 036

Pembroke Pines, Florida, United States

Site Status

Forest Investigative site 005

Pembroke Pines, Florida, United States

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Forest Investigative site 001

St. Petersburg, Florida, United States

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Forest Investigative site 004

Tampa, Florida, United States

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Forest Investigative site 046

Tampa, Florida, United States

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Forest Investigative site 076

Atlanta, Georgia, United States

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Forest Investigative site 055

Stockbridge, Georgia, United States

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Forest Investigative Site 070

Honolulu, Hawaii, United States

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Forest Investigative site 008

Meridian, Idaho, United States

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Forest Investigative site 016

Chicago, Illinois, United States

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Forest Investigative site 085

Chicago, Illinois, United States

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Forest Investigative site 082

Chicago, Illinois, United States

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Forest Investigative site 039

Morton, Illinois, United States

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Forest Investigative site 087

Louisville, Kentucky, United States

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Forest Investigative site 099

Madisonville, Kentucky, United States

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Forest Investigative site 060

Owensboro, Kentucky, United States

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Forest Investigative site 030

New Orleans, Louisiana, United States

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Forest Investigative site 069

Balitmore, Maryland, United States

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Forest Investigative site 021

Baltimore, Maryland, United States

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Forest Investigative site 014

Baltimore, Maryland, United States

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Forest Investigative site 054

Brockton, Massachusetts, United States

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Forest Investigative site 095

St Louis, Missouri, United States

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Forest Investigative site 010

Las Vegas, Nevada, United States

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Forest Investigative site 012

Las Vegas, Nevada, United States

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Forest Investigative site 020

Elizabeth, New Jersey, United States

Site Status

Forest Investigative site 065

Asheboro, North Carolina, United States

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Forest Investigative site 034

Charlotte, North Carolina, United States

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Forest Investigative site 086

Charlotte, North Carolina, United States

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Forest Investigative site 089

Hickory, North Carolina, United States

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Forest Investigative site 094

Hickory, North Carolina, United States

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Forest Investigative site 027

Lenoir, North Carolina, United States

Site Status

Forest Investigative site 101

Raleigh, North Carolina, United States

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Forest Investigative site 024

Raleigh, North Carolina, United States

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Forest Investigative site 013

Shelby, North Carolina, United States

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Forest Investigative site 022

Winston-Salem, North Carolina, United States

Site Status

Forest Investigative site 098

Cincinnati, Ohio, United States

Site Status

Forest Investigative site 084

Columbus, Ohio, United States

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Forest Investigative site 026

Dayton, Ohio, United States

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Forest Investigative site 051

Zanesville, Ohio, United States

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Forest Investigative site 053

Norman, Oklahoma, United States

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Forest Investigative site 062

Ashland, Oregon, United States

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Forest Investigative site 011

Broomall, Pennsylvania, United States

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Forest Investigative site 061

Philadelphia, Pennsylvania, United States

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Forest Investigative site 015

Tipton, Pennsylvania, United States

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Forest Investigative site 045

Cranston, Rhode Island, United States

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Forest Investigative site 066

Charleston, South Carolina, United States

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Forest Investigative site 048

Greer, South Carolina, United States

Site Status

Forest Investigative site 093

Mt. Pleasant, South Carolina, United States

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Forest Investigative site 052

Fayetteville, Tennessee, United States

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Forest Investigative site 025

Carrollton, Texas, United States

Site Status

Forest Investigative site 006

Houston, Texas, United States

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Forest Investigative site 029

Houston, Texas, United States

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Forest Investigative site 047

San Antonio, Texas, United States

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Forest Investigative site 071

San Antonio, Texas, United States

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Forest Investigative site 018

Salt Lake City, Utah, United States

Site Status

Forest Investigative site 100

Salt Lake City, Utah, United States

Site Status

Forest Investigative site 023

St. George, Utah, United States

Site Status

Forest Investigative site 031

Norfolk, Virginia, United States

Site Status

Forest Investigative site 041

Norfolk, Virginia, United States

Site Status

Forest Investigative site 078

Tacoma, Washington, United States

Site Status

Forest Investigative site 044

Caguas, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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NEB-MD-25

Identifier Type: -

Identifier Source: org_study_id

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