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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673790
• Other study ID #: NEB-MD-04
• Status: Completed
• Phase: Phase 4
• Start date: May 15, 2008
• Est. completion date: July 9, 2010

Study information

• Verified date: February 2020
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: July 9, 2010
• Est. primary completion date: July 9, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Hypertension

Intervention

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.
• 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 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.

Locations

Country	Name	City	State
United States	Forest Investigative Site 056	Anaheim	California
United States	Forest Investigative Site 126	Arlington	Virginia
United States	Forest Investigative Site 058	Athens	Alabama
United States	Forest Investigative Site 072	Atlanta	Georgia
United States	Forest Investigative Site 075	Atlanta	Georgia
United States	Forest Investigative Site 106	Auburn	Maine
United States	Forest Investigative Site 042	Augusta	Georgia
United States	Forest Investigative Site 097	Bell Gardens	California
United States	Forest Investigative Site 101	Birmingham	Alabama
United States	Forest Investigative Site 040	Bountiful	Utah
United States	Forest Investigative Site 067	Brockton	Massachusetts
United States	Forest Investigative Site 110	Brockton	Massachusetts
United States	Forest Investigative Site 071	Brooklyn	New York
United States	Forest Investigative Site 139	Brooksville	Florida
United States	Forest Investigative Site 026	Buena Park	California
United States	Forest Investigative Site 147	Buena Park	California
United States	Forest Investigative Site 003	Carrollton	Texas
United States	Forest Investigative Site 091	Centerville	Ohio
United States	Forest Investigative Site 035	Charlotte	North Carolina
United States	Forest Investigative Site 051	Charlotte	North Carolina
United States	Forest Investigative Site 082	Chicago	Illinois
United States	Forest Investigative Site 061	Chino	California
United States	Forest Investigative Site 089	Cincinnati	Ohio
United States	Forest Investigative Site 080	Columbia	Missouri
United States	Forest Investigative Site 098	Columbia	South Carolina
United States	Forest Investigative Site 103	Coral Gables	Florida
United States	Forest Investigative Site 108	Costa Mesa	California
United States	Forest Investigative Site 019	Daytona Beach	Florida
United States	Forest Investigative Site 010	DeLand	Florida
United States	Forest Investigative Site 077	Durham	North Carolina
United States	Forest Investigative Site 146	Elizabeth	New Jersey
United States	Forest Investigative Site 054	Encinitas	California
United States	Forest Investigative Site 087	Eugene	Oregon
United States	Forest Investigative Site 128	Fresno	California
United States	Forest Investigative Site 115	Greer	South Carolina
United States	Forest Investigative Site 114	Harleysville	Pennsylvania
United States	Forest Investigative Site 073	Hialeah	Florida
United States	Forest Investigative Site 109	Hialeah	Florida
United States	Forest Investigative Site 036	Hollywood	Florida
United States	Forest Investigative Site 094	Honolulu	Hawaii
United States	Forest Investigative Site 116	Houston	Texas
United States	Forest Investigative Site 127	Huntington Park	California
United States	Forest Investigative Site 016	Huntsville	Alabama
United States	Forest Investigative Site 123	Lafayette	Louisiana
United States	Forest Investigative Site 100	Lenoir	North Carolina
United States	Forest Investigative Site 030	Long Beach	California
United States	Forest Investigative Site 028	Los Angeles	California
United States	Forest Investigative Site 085	Los Angeles	California
United States	Forest Investigative Site 065	Madisonville	Kentucky
United States	Forest Investigative Site 95	Meridian	Idaho
United States	Forest Investigative Site 099	Miami	Florida
United States	Forest Investigative Site 104	Miami	Florida
United States	Forest Investigative Site 121	Miami	Florida
United States	Forest Investigative Site 074	Milford	Connecticut
United States	Forest Investigative Site 041	Morehead City	North Carolina
United States	Forest Investigative Site 124	National City	California
United States	Forest Investigative Site 081	New York	New York
United States	Forest Investigative Site 120	Odessa	Texas
United States	Forest Investigative Site 006	Oxon Hill	Maryland
United States	Forest Investigative Site 018	Paw Paw	Michigan
United States	Forest Investigative Site 083	Pawtucket	Rhode Island
United States	Forest Investigative Site 107	Pembroke Pines	Florida
United States	Forest Investigative Site 122	Perrysburg	Ohio
United States	Forest Investigative Site 119	Phoenix	Arizona
United States	Forest Investigative Site 088	Portland	Oregon
United States	Forest Investigative Site 117	Riverside	California
United States	Forest Investigative Site 025	Roseville	California
United States	Forest Investigative Site 017	Sacramento	California
United States	Forest Investigative Site 021	Saint Clair Shores	Michigan
United States	Forest Investigative Site 141	Saint Petersburg	Florida
United States	Forest Investigative Site 050	Salisbury	North Carolina
United States	Forest Investigative Site 062	Salt Lake City	Utah
United States	Forest Investigative Site 093	Salt Lake City	Utah
United States	Forest Investigative Site 012	San Antonio	Texas
United States	Forest Investigative Site 068	San Diego	California
United States	Forest Investigative Site 112	Santa Ana	California
United States	Forest Investigative Site 105	Simpsonville	South Carolina
United States	Forest Investigative Site 092	Sioux Falls	South Dakota
United States	Forest Investigative Site 048	Sugar Land	Texas
United States	Forest Investigative Site 140	Tampa	Florida
United States	Forest Investigative Site 063	Temecula	California
United States	Forest Investigative Site 078	Tucson	Arizona
United States	Forest Investigative Site 013	Tustin	California
United States	Forest Investigative Site 052	Walnut Creek	California
United States	Forest Investigative Site 130	West Jordan	Utah
United States	Forest Investigative Site 060	West Palm Beach	Florida
United States	Forest Investigative Site 125	West Palm Beach	Florida
United States	Forest Investigative Site 096	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Seated Diastolic Blood Pressure	Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).	Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)
Secondary	Plasma Glucose Level After an Oral Glucose Tolerance Test	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.	Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)