NCT00200421

Brief Summary

The purpose of this study is to determine the effects on exercise capacity of nebivolol compared to atenolol in hypertensive patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2 hypertension

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.1 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

December 16, 2005

Status Verified

August 1, 2003

First QC Date

September 12, 2005

Last Update Submit

December 15, 2005

Conditions

Hypertension

Keywords

NebivololAtenololExerciseHypertension

Outcome Measures

Primary Outcomes (1)

  • The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.

Secondary Outcomes (1)

  • The change in sub-maximal exercise duration at end of treatment compared to baseline.

Interventions

Nebivolol and AtenololDRUG

Eligibility Criteria

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

You may qualify if:

  • An average sitting diastolic blood pressure (DBP) 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 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

HypertensionMotor Activity

Interventions

NebivololAtenolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

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 2
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

May 1, 2002

Study Completion

August 1, 2003

Last Updated

December 16, 2005

Record last verified: 2003-08

Locations

US(1)