Effect of Chronic Statin and Viagra Therapy in Persons With Endothelial Cell Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00587379
Recruitment Status : Withdrawn (Study closed per the request of PI due to lack of participant accrual)
First Posted : January 7, 2008
Last Update Posted : January 13, 2012
Information provided by:
Mayo Clinic

Brief Summary:
To determine if 6 weeks of daily treatment with Atorvastatin 40 mg alters the immediate effect of Sildenafil Citrate (Viagra, Pfizer Inc, New York, NY) on endothelial function (activity of the artery) as measured by noninvasive peripheral arterial tonography in men and women. Also, to determine if 6 weeks of daily treatment with Atorvastatin 40 mg affects erectile function in men

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Drug: Atorvastatin Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Chronic Statin Therapy on Peripheral Arterial Tone Response to Sildenafil Citrate (Viagra), and on Erectile Function in Men With Coronary Artery Endothelial Cell Dysfunction
Study Start Date : June 2004
Actual Primary Completion Date : May 2008
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Patients randomized to take 1 40mg Atorvastain pill per day for 6 week study period
Drug: Atorvastatin
40 mg atorvastatin pill daily
Placebo Comparator: 2
Patients randomized to 1 40mg placebo pill per day for 6 week study
Drug: placebo
40 mg pill per day

Primary Outcome Measures :
  1. To determine if endothelial function as measured by Peripheral Arterial Tonometry improves over a 6 week period while on Atorvastatin. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. To determine if treatment with Atovastatin affects erectile function in men [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing coronary angiography
  • No previous statin use
  • Age > 18 years old
  • No PDE5-1 use in the past 6 months

Exclusion Criteria:

  • Patients with an Acute Coronary Syndrome
  • Patients with Cardiogenic shock
  • Patients > 30% coronary stenosis
  • Patients with unexplained muscle pain
  • Patients with acute liver disease
  • Patients receiving immunosuppressant therapy, azoles, macrolide antibiotics, niacin, L-arginine
  • Patients with serum creatinine > 2.0
  • Patients with total cholesterol > 200 mmol/l
  • Patients on current statin therapy or clinically indicated to be on statin therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00587379

Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Amir Lerman, MD Mayo Clinic

Responsible Party: Amir Lerman, M.D., Mayo Clinic Identifier: NCT00587379     History of Changes
Other Study ID Numbers: 328-04
2003-0359 - Pfizer
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by Mayo Clinic:
testing for Endothelial Dysfunction and coronary angiography

Additional relevant MeSH terms:
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors