A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

This study has been completed.

Sponsor:

Information provided by:

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT00785512

First received: November 3, 2008

Last updated: August 19, 2010

Last verified: August 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 3, 2008

Last Updated Date

August 19, 2010

Start Date ^ICMJE

November 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Trough Sitting Diastolic Blood Pressure [ Time Frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12) ] [ Designated as safety issue: No ]

Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.

Original Primary Outcome Measures ^ICMJE

Trough Sitting Diastolic Blood Pressure [ Time Frame: At Visit 9 and Visit 12 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00785512 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Trough Sitting Systolic Blood Pressure [ Time Frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12) ] [ Designated as safety issue: No ]

Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.

Original Secondary Outcome Measures ^ICMJE

Trough Sitting Systolic Blood Pressure [ Time Frame: At Visit 9 and Visit 12 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

Official Title ^ICMJE

A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy

Brief Summary

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Nebivolol
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration

Other Name: Bystolic® (nebivolol)
Drug: Placebo
Matching placebo tablets, oral administration

Study Arm (s)

Active Comparator: 1
Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration

Intervention: Drug: Nebivolol
Placebo Comparator: 2
Matching placebo tablets, oral administration

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

207

Completion Date

Not Provided

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

male and female outpatients 18 to 79 years of age
Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
meet criteria for stage I or II hypertension
currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion Criteria:

type 1 or type 2 diabetes
secondary hypertension
evidence of other concurrent disease or conditions that might interfere with the conduct of the study
treatment with any investigational study drug within 30 days of Screening (Visit 1)
have a history of hypersensitivity to nebivolol or other β-blockers

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00785512

Other Study ID Numbers ^ICMJE

NEB-MD-17

Has Data Monitoring Committee

Responsible Party

John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc

Study Sponsor ^ICMJE

Forest Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Tatjana Lukic, MD, MSc

Forest Research Institute, a Subsidiary of Forest Laboratories Inc.

Information Provided By

Forest Laboratories

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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