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

Endothelial Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00587379
• Other study ID #: 328-04
• Secondary ID: 2003-0359 - Pfiz
• Status: Withdrawn
• Phase: N/A
• First received: December 21, 2007
• Last updated: January 12, 2012
• Start date: June 2004
• Est. completion date: May 2008

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Drug:
• Atorvastatin
40 mg atorvastatin pill daily
• placebo
40 mg pill per day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if endothelial function as measured by Peripheral Arterial Tonometry improves over a 6 week period while on Atorvastatin.		6 weeks	No
Secondary	To determine if treatment with Atovastatin affects erectile function in men		6 weeks	No