The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose - Tabular View

Tracking Information

First Received Date ^ICMJE

April 29, 2008

Last Updated Date

October 28, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Trough seated diastolic blood pressure (DBP) [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Seated diastolic blood pressure (DBP) and plasma glucose level after an oral glucose tolerance test [ Time Frame: Before treatment and after 12 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00673790 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Plasma glucose level after an oral glucose tolerance test [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]
Homeostasis Model Assessment of Insulin Resistance [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]
Trough seated systolic blood pressure (SBP) [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]
Fasting Blood Glucose [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Homeostasis Model Assessment of Insulin Resistance; seated systolic blood pressure (SBP) [ Time Frame: Before treatment and during the 12 weeks of treatment ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose

Official Title ^ICMJE

Blood Pressure and Metabolic Effects of Nebivolol Compared With Hydrochlorothiazide and Placebo in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose

Brief Summary

This study is being done to see if the blood pressure and metabolic effects of an approved drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and placebo in hypertensive patients.

Detailed Description

This study is double blind (neither you nor the physician will know when you are receiving placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol or hydrochlorothiazide).

All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan, an angiotensin receptor blocker. All medications are approved and marketed for the treatment of hypertension.This study is being conducted in about 500 patients at approximately 80 research centers in the United States.

The study consists of approximately 9 study visits over a period of 5 months. During these visits, patients will undergo routine health exams and some special laboratory tests such as an oral glucose tolerance test.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Nebivolol
Drug: HCTZ
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: Nebivolol
Active Comparator: HCTZ
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Completion Date

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female, ambulatory outpatients 18-80 years old at screening.
Have a history of hypertension and taking up to 2 medications for high blood pressure.
Qualifying laboratory results confirming impaired fasting glucose or impaired glucose tolerance
Vision and hearing (hearing aid permissible) sufficient for compliance with questionnaire completion

Exclusion Criteria:

Have clinically significant respiratory, liver or cardiovascular disease
Presence of coronary artery disease requiring treatment with a beat blocker, calcium channel blocker or nitrates
Use of niacin or antidiabetic drugs (oral or injectable) within 6 months before study entry
Have a history of hypersensitivity to nebivolol, other beta-blockers, hydrochlorothiazide, or other sulfonamide-derived drugs.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sandra Beaird, PharmD

800/678/1605 ext 66297

info@forestpharm.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00673790

Responsible Party

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

Study ID Numbers ^ICMJE

NEB-MD-04

Study Sponsor ^ICMJE

Forest Laboratories

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Kati Gutierrez, PharmD, PhD

Forest Research Institute, a subdisiary of Forest Laboratories, Inc.

Information Provided By

Forest Laboratories

Verification Date

October 2009

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