Text Size

Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries (EFFORT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
George L Bakris, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT00829296
First received: January 26, 2009
Last updated: January 22, 2013
Last verified: January 2013
History of Changes

January 26, 2009
January 22, 2013
January 2009
April 2012   (final data collection date for primary outcome measure)
It is thought that reducing the stiffness of arteries may provide an additional benefit in reducing the risk of death. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00829296 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries
The Effects of Nebivolol on Aortic Impendance Parameters in Type 2 Diabetics

The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.

To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Stiffness of the Arteries
Drug: nebivolol
taken once daily
Other Name: bystolic
Experimental: nebivolol
bystolic
Intervention: Drug: nebivolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2013
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Established Type 2 diabetic not treated with insulin
  • Stage 1 hypertensives blood pressure > 130/80 mmHg and < 160/100 mmHg
  • BMI < 35
  • Hemoglobin A1C < 8.5
  • Must be postmenopausal or taking some form of birth control of surgically sterile

Exclusion Criteria:

  • Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
  • Active angina in the last three months
  • Diabetes requiring treatment with insulin
  • Severe asthma
  • Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception
  • Recent history of substance or alcohol abuse .
  • Uncontrolled hypertension systolic blood pressure >160mmHg or diastolic blood pressure > 100 mmHg
Both
50 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829296
16310B (EFFORT trial)
No
George L Bakris, MD, University of Chicago
University of Chicago
Forest Laboratories
Principal Investigator: George Bakris, M.D. University of Chicago
University of Chicago
January 2013

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