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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00673790
First received: April 29, 2008
Last updated: September 22, 2010
Last verified: September 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

  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:

  • 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 ClinicalTrials.gov identifier: NCT00673790

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

No publications provided

Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00673790     History of Changes
Other Study ID Numbers: NEB-MD-04
Study First Received: April 29, 2008
Last Updated: September 22, 2010
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

Additional relevant MeSH terms:
Hypertension
Glucose Intolerance
Prediabetic State
Vascular Diseases
Cardiovascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hydrochlorothiazide
Nebivolol
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 20, 2014