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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Collaborator:
Pfizer
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587379
First received: December 21, 2007
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Statins
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if treatment with Atovastatin affects erectile function in men [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587379

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

No publications provided

Responsible Party: Amir Lerman, M.D., Mayo Clinic
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013