The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
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|ClinicalTrials.gov Identifier: NCT00673790|
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : September 23, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Nebivolol Drug: HCTZ Drug: Placebo||Phase 4|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Primary Completion Date :||July 2010|
Active Comparator: 1
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration
Active Comparator: 2
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration.
Placebo Comparator: 3
- Trough seated diastolic blood pressure (DBP) [ Time Frame: Change from Baseline To Week 12 ]
- 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 ]
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
|Study Director:||John Shea, MS||Forest Research Institute, a subdisiary of Forest Laboratories, Inc.|