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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00673790
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : September 23, 2010
Information provided by:
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol Drug: HCTZ Drug: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2008
Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Drug: Nebivolol
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration
Active Comparator: 2
Drug: HCTZ
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration.
Placebo Comparator: 3
Drug: Placebo

Primary Outcome Measures :
  1. Trough seated diastolic blood pressure (DBP) [ Time Frame: Change from Baseline To Week 12 ]

Secondary Outcome Measures :
  1. Plasma glucose level after an oral glucose tolerance test [ Time Frame: Change from Baseline To Week 12 ]
  2. Homeostasis Model Assessment of Insulin Resistance [ Time Frame: Change from Baseline To Week 12 ]
  3. Trough seated systolic blood pressure (SBP) [ Time Frame: Change from Baseline To Week 12 ]
  4. Fasting Blood Glucose [ Time Frame: Change from Baseline To Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00673790

  Show 88 Study Locations
Sponsors and Collaborators
Forest Laboratories
Study Director: John Shea, MS Forest Research Institute, a subdisiary of Forest Laboratories, Inc.

Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc. Identifier: NCT00673790     History of Changes
Other Study ID Numbers: NEB-MD-04
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: September 23, 2010
Last Verified: September 2010

Keywords provided by Forest Laboratories:
Prinivil (TM)
Zestril (TM)
Cozaar (TM)
Impaired Fasting Glucose
Impaired Glucose Tolerance

Additional relevant MeSH terms:
Glucose Intolerance
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents