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

This study has been withdrawn prior to enrollment.
(Study closed per the request of PI due to lack of participant accrual)
Information provided by:
Mayo Clinic Identifier:
First received: December 21, 2007
Last updated: January 12, 2012
Last verified: January 2012
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 Intervention
Endothelial Dysfunction Drug: Atorvastatin Drug: placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

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

Enrollment: 0
Study Start Date: June 2004
Estimated Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00587379

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

Responsible Party: Amir Lerman, M.D., Mayo Clinic Identifier: NCT00587379     History of Changes
Other Study ID Numbers: 328-04
2003-0359 - Pfizer
Study First Received: December 21, 2007
Last Updated: January 12, 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 processed this record on September 20, 2017