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Tadalafil Study
Principal Investigator Name:Susan Zieman, M.D. Ph.D
 
Study Coordinator Name:Kristy Kessler R.N.
Contact Phone:

410-955-9864

Contact E-mail:kswiger1@jhmi.edu
Study Short Title:Tadalafil study
Study Long Title:Tadalafil for the Treatment of Hypertensive Heart Disease and Ventricular Hypertrophy
IRB Number:NA_00001634
Funding Source:Lilly ICOS Inc.
Summary of Trial:

Volunteers with Stable High Blood Pressure Are Needed for a 28 week Research Study with Oral  Tadalafil (IRB # NA00001634)

We are enrolling men and women 30-85 years old with high blood pressure for a 6 month study comparing the effects of Cialis® (Tadalafil) with a placebo (inactive substance) on the heart.  Tadalafil is a medicine similar to Viagra® that is commonly used to treat male erectile dysfunction.

Participation involves a screening visit with ultrasound testing and examination.  If eligible, volunteers will receive daily study drug and come to Johns Hopkins Hospital for monthly visits with exercise testing, ultrasound, and MRI of the heart.

Inclusions:

To be in this study you must meet the following qualifications:

      1.   Male or female age 30-85 years old
      2.   Have high blood pressure
      3.   Have thickened heart muscle due to high blood pressure
      4.   Normal ejection fraction (EF ≥ 50%)
      5.   50% of subjects will have diabetes

Exclusions:You cannot:
     1.    Have HIV or AIDS
     2.    Have heart failure
     3.    Have a pacemaker, defibrillator or implantable device.
     4.    Have Atrial fibrillation
     5.    Have had a heart attack or stroke within the last 6 months.
     6.    Some other exclusions may apply
Clinical Trial Site:The Johns Hopkins Hospital
600 N. Wolfe Street
Baltimore, MD 21287
Compensation for Participating?

Eligible volunteers will receive $40.00 per completed study visit, and a parking voucher on the day of their visits.

Start Date:July 2006
Anticipated End Date:December 2007

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