Endothelial DysfunctionNCT00587379
Effect of Chronic Statin and Viagra Therapy in Persons With Endothelial Cell Dysfunction
A study testing Atorvastatin in people with Endothelial Dysfunction, run by Mayo Clinic.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing coronary angiography
- No previous statin use
- Age > 18 years old
- No PDE5-1 use in the past 6 months
Who cannot join
- 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
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- 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
About this study
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
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
- Conditions
- Endothelial Dysfunction
- Being tested
- Atorvastatin, placebo
- Keywords
- testing for Endothelial Dysfunction and coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
40 mg atorvastatin pill daily
placeboDrug
40 mg pill per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients randomized to take 1 40mg Atorvastain pill per day for 6 week study period Receives: Drug: Atorvastatin |
| 2 | Placebo comparator | Patients randomized to 1 40mg placebo pill per day for 6 week study Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if endothelial function as measured by Peripheral Arterial Tonometry improves over a 6 week period while on Atorvastatin.
Measured: 6 weeks
Secondary outcomes (1)
To determine if treatment with Atovastatin affects erectile function in men
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJun 2004
- Primary completionMay 2008
- Study completionMay 2008 (estimated)
Why it stopped: Study closed per the request of PI due to lack of participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Amir Lerman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587379
- Sponsor's protocol ID
- 328-04
- Other IDs
- 2003-0359 - Pfizer
- Status last verified
- Jan 2012
- First submitted
- 21 Dec 2007
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00587379
- Acronym / sponsor ID
- 328-04
- Conditions
- Endothelial Dysfunction
- Keywords
- testing for Endothelial Dysfunction and coronary angiography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed per the request of PI due to lack of participant accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (estimated)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AtorvastatinPatients randomized to take 1 40mg Atorvastain pill per day for 6 week study period |
| 2 | Placebo comparator | Drug: placeboPatients randomized to 1 40mg placebo pill per day for 6 week study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing coronary angiography
- No previous statin use
- Age > 18 years old
- No PDE5-1 use in the past 6 months
Key exclusion criteria (9 listed)
- Patients with an Acute Coronary Syndrome
- Patients with Cardiogenic shock
- Patients > 30% coronary stenosis
- Patients with unexplained muscle pain
- Patients with acute liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin40 mg atorvastatin pill daily | Drug | 1 |
| placebo40 mg pill per day | Drug | 2 |
Primary outcome
To determine if endothelial function as measured by Peripheral Arterial Tonometry improves over a 6 week period while on Atorvastatin.
Time frame: 6 weeks
1 secondary outcome
To determine if treatment with Atovastatin affects erectile function in men
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Lerman, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin in people with Endothelial Dysfunction, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if endothelial function as measured by Peripheral Arterial Tonometry improves over a 6 week period while on Atorvastatin. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.