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

This study has been completed.
Information provided by:
Forest Laboratories Identifier:
First received: April 29, 2008
Last updated: September 22, 2010
Last verified: September 2010
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
Drug: Nebivolol
Drug: HCTZ
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

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

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

Enrollment: 543
Study Start Date: May 2008
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00673790

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

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
Study First Received: April 29, 2008
Last Updated: September 22, 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 processed this record on April 25, 2017