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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.
 
ClinicalTrials.gov Identifier: NCT00673790
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
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 with concomitant losartan or lisinopril Drug: HCTZ with concomitant losartan or lisinopril Drug: Placebo with concomitant losartan or lisinopril 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 537 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
Actual Study Start Date : May 15, 2008
Actual Primary Completion Date : July 9, 2010
Actual Study Completion Date : July 9, 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nebivolol
Nebivolol with concomitant losartan or lisinopril
Drug: Nebivolol with concomitant losartan or lisinopril
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

Active Comparator: Hydrochlorothiazide (HCTZ)
HCTZ with concomitant losartan or lisinopril
Drug: HCTZ with concomitant losartan or lisinopril
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

Placebo Comparator: Placebo
Placebo with concomitant losartan or lisinopril
Drug: Placebo with concomitant losartan or lisinopril
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.




Primary Outcome Measures :
  1. Trough Seated Diastolic Blood Pressure [ Time Frame: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12) ]
    Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).


Secondary Outcome Measures :
  1. Plasma Glucose Level After an Oral Glucose Tolerance Test [ Time Frame: Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12) ]
    Change from Baseline in Plasma Glucose 2 Hours Post-oral Glucose 75 grams, given as part of an Oral Glucose Tolerance Test (OGTT). Last Observation Carried Forward.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00673790


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

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00673790    
Other Study ID Numbers: NEB-MD-04
First Posted: May 7, 2008    Key Record Dates
Results First Posted: February 26, 2020
Last Update Posted: February 26, 2020
Last Verified: February 2020
Keywords provided by Forest Laboratories:
hydrochlorothiazide
losartan
Cozaar (TM)
nebivolol
BYSTOLIC ™
lisinopril
Prinivil (TM)
Zestril (TM)
Impaired Fasting Glucose
Impaired Glucose Tolerance
hypertension
Additional relevant MeSH terms:
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Losartan
Hydrochlorothiazide
Hypertension
Glucose Intolerance
Vascular Diseases
Cardiovascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Nebivolol
Lisinopril
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors