Effect of Chronic Statin and Viagra Therapy in Persons With Endothelial Cell Dysfunction - Full Text View

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

ChemIDplus related topics:

Sildenafil citrate Sildenafil Atorvastatin Atorvastatin calcium Citric acid Sodium Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

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 ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients randomized to take 1 40mg Atorvastain pill per day for 6 week study period	Drug: Atorvastatin 40 mg atorvastatin pill daily
2: Placebo Comparator 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

Contacts


Contact: Lerman Amir, M.D.	507-255-5123 ext 4152	amir.lerman@yahoo.com

Locations


United States, Minnesota
	Mayo Clinic	Not yet recruiting
	rochester, Minnesota, United States, 55905
	Contact: Amir Lerman, MD 507-255-5123 ext 4152 amir.lerman@mayo.edu
	Principal Investigator: Amir Lerman, MD
	Principal Investigator: Amir Lerman, MD

Sponsors and Collaborators

Mayo Clinic

Pfizer

Investigators


Principal Investigator:	Amir Lerman, MD	Mayo Clinic

More Information

Responsible Party:	Mayo Clinic ( Amir Lerman, M.D. )
Study ID Numbers:	328-04, 2003-0359 - Pfizer
First Received:	December 21, 2007
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00587379
Health Authority:	United States: Food and Drug Administration