A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension

• Sponsor: Mylan Bertek Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00200434
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 50

Study Details

Study Description

Brief Summary

The purpose of this study was to contrast the efficacy and safety of 3 dose levels of nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for 3 months, in patients with mild to moderate hypertension

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Nebivolol	Phase 3

Detailed Description

Following a washout of any previous beta-blocker medication, if applicable, supine, sitting, and standing cuff blood pressure and pulse rate, 24-hour ambulatory blood pressure monitoring (ABPM), ECG, laboratory assessments and genomics testing were performed before randomization. Patients were randomized to receive placebo or nebivolol once daily in the morning together with their curently prescribed antihypertensive therapy. Patients had four scheduled clinical visits during the study, following the screening visit.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Mild to Moderate Hypertension
• Study Start Date: Oct 1, 2002
• Study Completion Date: Oct 1, 2003

Outcome Measures

Primary Outcome Measures

1. The change from baseline to week 12 in the average sitting DBP at trough. []

Secondary Outcome Measures

1. Change from baseline to week 2, 6, and 12 in the average sitting, supine, standing systolic and diastolic blood pressure and sitting HR. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Average sitting diastolic blood pressure (DBP) greater then or equal to 90 mmHg and less then or equal to 109 mmHg at screening and baseline, in patients on background antihypertensive therapy taking at least one and no more than two of either ACE inhibitor, ARB, or diuretic.

Exclusion Criteria:

• Recent myocardial infarction or stroke

• Contraindications to beta-blocker therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mylan Pharmaceuticals Inc.	Morgantown	West Virginia	United States	26505

Sponsors and Collaborators

• Mylan Bertek Pharmaceuticals

Investigators

• Study Director: Betty S. Riggs, MD, MBA, Mylan Pharmaceuticals Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00200434
• Other Study ID Numbers: NEB321
• First Posted: Sep 20, 2005
• Last Update Posted: Sep 20, 2005
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: Nebivolol; Beta-Blocker; Hypertension
• Additional relevant MeSH terms: Hypertension; Nebivolol

Study Results

No Results Posted as of Sep 20, 2005