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A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00200499
First received: September 13, 2005
Last updated: December 15, 2005
Last verified: September 2005
History of Changes

September 13, 2005
December 15, 2005
March 2002
Not Provided
The change in average sitting diastolic blood pressure measured at trough drug plasma level at the end of the extension phase compared to baseline of NEB 202, NEB 302 or NEB 305.
Same as current
Complete list of historical versions of study NCT00200499 on ClinicalTrials.gov Archive Site
  • Change in the average
  • - sitting systolic blood pressure
  • - supine and standing systolic and diastolic blood pressure
  • - response rate of treatment groups
  • - AEs
  • - ECGs
  • - laboratory parameters
  • - heart rate
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients
A Multi-Center, Parallel Group Extension Study to Determine the Safety and Efficacy of Long-Term Nebivolol Exposure in Patients With Mild to Moderate Hypertension

The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.

This was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension (defined as an average sitting diastolic blood pressure greater then or equal to 95 mmHg and less then or equal to 109 mmHg when untreated, based on entry into NEB 202, NEB 302 or NEB 305). Patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist. After successful completion of one of the 3-month efficacy "feeder" studies, patients were eligible to continue nebivolol treatment in this 9-month extension study. Patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: Nebivolol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
845
September 2003
Not Provided

Inclusion Criteria:

  • To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB 305. To enter the 4-week follow-up phase, patients must have completed NEB-306 (extension phase) and received only nebivolol monotherapy treatment during NEB 306.

Exclusion Criteria:

  • Secondary hypertension
  • myocardial infarction or stroke
  • contraindications to beta-blocker therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200499
NEB306
Not Provided
Not Provided
Mylan Bertek Pharmaceuticals
Not Provided
Study Director: Betty S. Riggs, MD, MBA Mylan Pharmaceuticals
Mylan Bertek Pharmaceuticals
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP