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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This study has been withdrawn prior to enrollment.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

December 21, 2007
January 12, 2012
June 2004
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00587379 on ClinicalTrials.gov Archive Site
To determine if treatment with Atovastatin affects erectile function in men [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Chronic Statin and Viagra Therapy in Persons With Endothelial Cell Dysfunction
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

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Endothelial Dysfunction
  • Drug: Atorvastatin
    40 mg atorvastatin pill daily
  • Drug: placebo
    40 mg pill per day
  • Active Comparator: 1
    Patients randomized to take 1 40mg Atorvastain pill per day for 6 week study period
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: 2
    Patients randomized to 1 40mg placebo pill per day for 6 week study
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00587379
328-04, 2003-0359 - Pfizer
No
Amir Lerman, M.D., Mayo Clinic
Mayo Clinic
Pfizer
Principal Investigator: Amir Lerman, MD Mayo Clinic
Mayo Clinic
January 2012

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