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Trial record 71 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

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
Last Update Posted : September 23, 2010
Sponsor:
Information provided by:
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE April 29, 2008
First Posted Date  ICMJE May 7, 2008
Last Update Posted Date September 23, 2010
Study Start Date  ICMJE May 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
Trough seated diastolic blood pressure (DBP) [ Time Frame: Change from Baseline To Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2008)
Seated diastolic blood pressure (DBP) and plasma glucose level after an oral glucose tolerance test [ Time Frame: Before treatment and after 12 weeks ]
Change History Complete list of historical versions of study NCT00673790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2008)
Homeostasis Model Assessment of Insulin Resistance; seated systolic blood pressure (SBP) [ Time Frame: Before treatment and during the 12 weeks of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
Official Title  ICMJE Blood Pressure and Metabolic Effects of Nebivolol Compared With Hydrochlorothiazide and Placebo in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Nebivolol
    Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration
  • Drug: HCTZ
    Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration.
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: 1
    Nebivolol
    Intervention: Drug: Nebivolol
  • Active Comparator: 2
    HCTZ
    Intervention: Drug: HCTZ
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2010)
543
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2008)
450
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00673790
Other Study ID Numbers  ICMJE NEB-MD-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Shea, MS Forest Research Institute, a subdisiary of Forest Laboratories, Inc.
PRS Account Forest Laboratories
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP