NCT00587379

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 13, 2012

Status Verified

January 1, 2012

Enrollment Period

3.9 years

First QC Date

December 21, 2007

Last Update Submit

January 12, 2012

Conditions

Endothelial Dysfunction

Keywords

testing for Endothelial Dysfunction and coronary angiography

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Secondary Outcomes (1)

  • To determine if treatment with Atovastatin affects erectile function in men

    6 weeks

Study Arms (2)

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

AtorvastatinDRUG

40 mg atorvastatin pill daily

1
placeboDRUG

40 mg pill per day

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing coronary angiography
  • No previous statin use
  • Age \> 18 years old
  • No PDE5-1 use in the past 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Amir Lerman, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

June 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 13, 2012

Record last verified: 2012-01