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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Patients randomized to take 1 40mg Atorvastain pill per day for 6 week study period

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

40 mg atorvastatin pill daily

2

Patients randomized to 1 40mg placebo pill per day for 6 week study

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

40 mg pill per day

Interventions

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Atorvastatin

40 mg atorvastatin pill daily

Intervention Type DRUG

placebo

40 mg pill per day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No