NCT00200473

Brief Summary

A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Sep 2001

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Hypertension

Keywords

NebivololHypertensionBeta-Blockers

Outcome Measures

Primary Outcomes (1)

  • The change of the average sitting diastolic blood pressure (24 plus/or minus 2 hours post-previous morning's dose) taken at trough at the end of the treatment compared to baseline

Secondary Outcomes (2)

  • - The change of the average sitting, supine and standing systolic and diastolic blood pressure at trough and peak at end of treatment compared to baseline

  • - Response rate

Interventions

NebivololDRUG

Eligibility Criteria

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

You may qualify if:

  • An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline

You may not qualify if:

  • Recent myocardial infarction or stroke
  • Secondary hypertension
  • Contraindications to beta-blocker therapy or discontinuation of prior antihypertensive agents
  • Pregnancy, nursing or women of childbearing age not using appropriate contraception

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
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2001

Study Completion

March 1, 2003

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations

US(1)