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

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Nebivolol Drug: HCTZ Drug: Placebo	Phase IV

MedlinePlus related topics:

High Blood Pressure

Drug Information available for:

Lisinopril Hydrochlorothiazide Nebivolol Dextrose Losartan Losartan potassium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	450
Study Start Date:	May 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Nebivolol	Drug: Nebivolol Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration
2: Active Comparator HCTZ	Drug: HCTZ Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration.
3: Placebo Comparator Placebo	Drug: Placebo Placebo

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 450 patients at approximately 60 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

History of smoking (use of tobacco products within 6 months of study entry and at any time during the study.
Have clinically significant respiratory, liver or cardiovascular disease
Presence of coronary artery disease requiring treatmetn 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673790

Show 55 Study Locations

Sponsors and Collaborators

Forest Laboratories

Investigators


Study Director:	David Bharucha, MD, PhD	Forest Laboratories

More Information

Responsible Party:	Forest Laboratories, Inc. ( Leslie Lipka, MD, PhD / Executive Director )
Study ID Numbers:	NEB-MD-04
First Received:	April 29, 2008
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00673790
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

nebivolol

BYSTOLIC ™

hydrochlorothiazide

lisinopril

Prinivil (TM)

Zestril (TM)

losartan

Cozaar (TM)

Impaired Fasting Glucose

Impaired Glucose Tolerance

hypertension

Study placed in the following topic categories:

Losartan

Metabolic Diseases

Hyperglycemia

Lisinopril

Glucose Intolerance

Vascular Diseases

Nebivolol

Metabolic disorder

Glucose Metabolism Disorders

Hydrochlorothiazide

Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents

Vasodilator Agents

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Diuretics

Physiological Effects of Drugs

Sodium Chloride Symporter Inhibitors

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Membrane Transport Modulators

Natriuretic Agents

Therapeutic Uses

Adrenergic beta-Antagonists

Adrenergic Antagonists

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00673790