Conditions: Hypertension
Keywords: nebivolol BYSTOLIC ™ hydrochlorothiazide lisinopril Prinivil (TM) Zestril (TM) losartan Cozaar (TM) Impaired Fasting Glucose Impaired Glucose Tolerance hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 537
Healthy volunteers: no

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.

Arms:
arm 1: Nebivolol with concomitant losartan or lisinopril arm 2: HCTZ with concomitant losartan or lisinopril arm 3: Placebo with concomitant losartan or lisinopril

Interventions: intervention 1: Nebivolol with concomitant losartan or lisinopril intervention 2: HCTZ with concomitant losartan or lisinopril intervention 3: Placebo with concomitant losartan or lisinopril
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

Protocol document: