Effect of Chronic Statin and Viagra Therapy in Persons Wi... | NCT00587379

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

NCT00587379

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Jan 13, 2012Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Endothelial Dysfunction

Interventions

Atorvastatin
placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2003-0359 - Pfizer

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study closed per the request of PI due to lack of participant accrual

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

May 2008Actual

Completion Date

May 2008Estimated

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Jan 4, 2008

First Posted Date

Jan 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2012

Last Update Posted Date

Jan 13, 2012Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Patients randomized to take 1 40mg Atorvastain pill per day for 6 week study period	Drug: Atorvastatin
2	Placebo Comparator	Patients randomized to 1 40mg placebo pill per day for 6 week study	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug	40 mg atorvastatin pill daily	1
placebo

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Amir Lerman, MD	Mayo Clinic	Principal Investigator

Intervention Browse Module

MeSH Terms

ID	Term
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided