NCT00200499

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
845

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Mar 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

December 16, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

December 15, 2005

Conditions

Hypertension

Keywords

NebivololHypertensionBeta-Blocker

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (8)

  • Change in the average

  • - sitting systolic blood pressure

  • - supine and standing systolic and diastolic blood pressure

  • - response rate of treatment groups

  • - AEs

  • +3 more secondary outcomes

Interventions

NebivololDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Secondary hypertension
  • myocardial infarction or stroke
  • contraindications to beta-blocker therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Betty S. Riggs, MD, MBA

    Mylan Pharmaceuticals Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

March 1, 2002

Study Completion

September 1, 2003

Last Updated

December 16, 2005

Record last verified: 2005-09

Locations

US(1)