PsoriasisPhase 3NCT01527097
Influence of Atorvastatin on Psoriasis Severity and Endothelial Function
A Phase 3 study testing Atorvastatin in people with Psoriasis, run by shmuel fuchs at 1 site in Israel.
Trial summary
Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and involvement of cells of the immune system. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Apr 2015
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 20 years
- Patients with psoriasis of at least 3-years duration
- Current moderate to severe psoriatic disease (PASI ≥12, IGA≥3)
- Statin-naïve patients
- No history of cardiovascular disease (ischemic heart disease, peripheral vascular disease or cerebrovascular disease)
- LDL levels
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- LDL level > 70 mg% and < 160 mg% in low risk patients (defined as having none or a single risk factor*)
- LDL > 70 mg% and < 130 mg% in moderate risk patients (defined as the presence of 2 or more risk factors*)
- LDL > 70 mg% and < 100 mg% in patients with type II diabetes
- hsCRP ≥ 1 mg/l * Risk factors: smoking, hypertension (blood pressure > 140/90 or current treatment with blood pressure lowering agents, HDL < 40 mg%, family history of premature coronary artery disease in a first degree relative younger than 45 (men) or 55 (women) and obesity (BMI ≥ 30).
Who cannot join
- Current statin therapy
- Patents with Atrial Fibrillation
- Elevated liver enzymes (> X3 ULN)
- History of statin-induced liver enzyme elevation
- Elevated CPK levels (> X3 ULN)
- History of myopathy including statin-induced
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- Severe chronic renal failure (GFR <30 ml/min)
- Pregnant or breast-feeding women
- Individuals at risk for poor protocol, or medication compliance
- Patients with life-expectancy of less than 2 years
- Patients who are currently participating in another clinical trial
- Other current active inflammatory and/or infectious conditions
- Sensitivity to any of atorvastatin ingredients
- Concomitant drug therapy, taken on a regular basis, which may interact with Atorvastatin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atorvastatin to Reduce Psoriasis Severity and Improve Endothelial Function in Patients With Severe Psoriasis and Non-Elevated LDL Levels: A Randomized, Double Blind, Placebo-Controlled Study.
Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and involvement of cells of the immune system. Atherosclerosis is frequently treated by statins (class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce inflammation. Some new evidences also suggest that therapy with statins may improve psoriasis skin disease.
The current study aims are to evaluate whether a strong statin named Atorvastatin can improve psoriatic skin disease and functioning of the arteries. The study also aims to evaluate if the activity of these two diseases are related to levels of common inflammatory biomarkers (substance in blood) and whether Atorvastatin can change their levels.
- Conditions
- Psoriasis
- Being tested
- Atorvastatin, Atorvastatin placebo
- Keywords
- Cardiovascular Diseases, Pharmacologic Actions, Endothelial Function, Dermatology, Inflammatory Disease, Skin Disease
- Medical subject headings
- Psoriasis, Cardiovascular Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
Drug: Atorvastatin 80 mg for 6 months following by 40 mg for additional 6 months once daily.
Atorvastatin placeboDrug
Atorvastatin 80mg during 6 month and 40mg in additional 6 month period once daily.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Not described Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Atorvastatin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome variable of the study is defined as the composite endpoint of improving of psoriatic severity and endothelial function (assessed by FMD changes).
Patient invited to clinic visits at 3,6 and 12 month follow up.At this visits in addition primary outcome will be measured.
Measured: 3,6 and 12 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: We strongly feel that the ability to recruit the required number of patients is very low and thus decided to stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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 3
- 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
- shmuel fuchs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, shmuel fuchs, Rabin Medical Center
- Investigators
- Shmuel Fuchs, Professor, Study director, Rabin Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527097
- Sponsor's protocol ID
- 0263 - 11 - RMC
- Status last verified
- Nov 2015
- First submitted
- 15 Jan 2012
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin to Reduce Psoriasis Severity and Improve Endothelial Function in Patients With Severe Psoriasis and Non-Elevated LDL Levels: A Randomized, Double Blind, Placebo-Controlled Study.
- ClinicalTrials.gov ID
- NCT01527097
- Acronym / sponsor ID
- 0263 - 11 - RMC
- Conditions
- Psoriasis
- Keywords
- Cardiovascular Diseases, Pharmacologic Actions, Endothelial Function, Dermatology, Inflammatory Disease, Skin Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We strongly feel that the ability to recruit the required number of patients is very low and thus decided to stop the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- shmuel fuchsUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Feb 2012 (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.
Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and involvement of cells of the immune system. Atherosclerosis is frequently treated by statins (class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce inflammation. Some new evidences also suggest that therapy with statins may improve psoriasis skin disease.
The current study aims are to evaluate whether a strong statin named Atorvastatin can improve psoriatic skin disease and functioning of the arteries. The study also aims to evaluate if the activity of these two diseases are related to levels of common inflammatory biomarkers (substance in blood) and whether Atorvastatin can change their levels.
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 |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin |
| Placebo | Placebo comparator | Drug: Atorvastatin placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients older than 20 years
- Patients with psoriasis of at least 3-years duration
- Current moderate to severe psoriatic disease (PASI ≥12, IGA≥3)
- Statin-naïve patients
- No history of cardiovascular disease (ischemic heart disease, peripheral vascular disease or cerebrovascular disease)
Key exclusion criteria (14 listed)
- Current statin therapy
- Patents with Atrial Fibrillation
- Elevated liver enzymes (> X3 ULN)
- History of statin-induced liver enzyme elevation
- Elevated CPK levels (> X3 ULN)
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 |
|---|---|---|
| AtorvastatinAlso: LipitorDrug: Atorvastatin 80 mg for 6 months following by 40 mg for additional 6 months once daily. | Drug | Atorvastatin |
| Atorvastatin placeboAtorvastatin 80mg during 6 month and 40mg in additional 6 month period once daily. | Drug | Placebo |
Primary outcome
The primary efficacy outcome variable of the study is defined as the composite endpoint of improving of psoriatic severity and endothelial function (assessed by FMD changes).
Time frame: 3,6 and 12 months after randomization.
Patient invited to clinic visits at 3,6 and 12 month follow up.At this visits in addition primary outcome will be measured.
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 17 Nov 2015.
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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.
Shmuel Fuchs, Professor study director
Rabin Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Psoriasis, run by shmuel fuchs at 1 site in Israel.
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 10 inclusion and 14 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 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary efficacy outcome variable of the study is defined as the composite endpoint of improving of psoriatic severity and endothelial function (assessed by FMD changes). (time frame: 3,6 and 12 months after randomization.). 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 17 Nov 2015.