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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00587379

Enrollment

Registered

2008-01-07

Start date

2004-06-30

Completion date

2008-05-31

Last updated

2012-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction

Keywords

testing for Endothelial Dysfunction and coronary angiography

Brief 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

Interventions

DRUGAtorvastatin

40 mg atorvastatin pill daily

DRUGplacebo

40 mg pill per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine if endothelial function as measured by Peripheral Arterial Tonometry improves over a 6 week period while on Atorvastatin.	6 weeks

Secondary

Measure	Time frame
To determine if treatment with Atovastatin affects erectile function in men	6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026