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P021

Peptide 021, GLXC-21260

Quick Stats
Studies 37
Trials 57
Completed PHASE4 INTERVENTIONAL NCT00673790

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: Nebivolol with concomitant losartan or lisinopril
Type: DRUG
Description: 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.
Name: HCTZ with concomitant losartan or lisinopril
Type: DRUG
Description: 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.
Name: Placebo with concomitant losartan or lisinopril
Type: DRUG
Description: Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

Primary Outcomes

Measure: Trough Seated Diastolic Blood Pressure
TimeFrame: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)
Description: Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).

Trial Information

NCT ID

NCT00673790

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Forest Laboratories

Last Updated

December 15, 2025