NCT00145210

Brief Summary

The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
630

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Apr 2005

Typical duration for phase_3 hypertension

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

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 7, 2008

Status Verified

September 1, 2005

Enrollment Period

2.4 years

First QC Date

September 1, 2005

Last Update Submit

March 6, 2008

Conditions

Hypertension

Keywords

Nebivolol

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

  • Heart Rate

Secondary Outcomes (1)

  • Safety and tolerability

Interventions

Nebivolol and AtenololDRUG

Eligibility Criteria

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

You may qualify if:

  • African Americans with stage 1-2 hypertension

You may not qualify if:

  • Recent myocardial infarction or stroke
  • Contraindications to beta-blocker therapy or stopping prior antihypertensive 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

NebivololAtenolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

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 1, 2005

First Posted

September 5, 2005

Study Start

April 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

March 7, 2008

Record last verified: 2005-09

Locations

US(1)