Systemic Lupus ErythematosusPhase 4NCT00739050

Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)

A Phase 4 study testing simvastatin in people with Systemic Lupus Erythematosus, run by Organon and Co.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: No sites listed yet
Study dates: 19 Sep 2007to 1 Feb 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female Patients Over 18 Years Old
Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)
Signed Informed Consent Form (ICF)

Who cannot join

Patients With LDL-C Below 90 mg/dL
Pregnant Or Breast Feeding
Diabetes Mellitus
Or Any Clinically Relevant Organ Disfunction

About this study

Official title: Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus

Conditions: Systemic Lupus Erythematosus
Being tested: simvastatin, Comparator: Placebo
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

simvastatinDrug
Also called Zocor, MK0733
simvastatin 20mg daily at nights for 12 weeks. Tablets
Comparator: PlaceboDrug
placebo daily at nights for 12 weeks. Tablets

Study groups in NCT00739050
Study group	Role	What they receive
1	Experimental	Arm 1: Drug Receives: Drug: simvastatin
2	Placebo comparator	Arm 2: Placebo Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
The study was terminated; no outcome measure data analyses were conducted.
Measured: Baseline and 12 weeks

Secondary outcomes (3)

Change in Total Cholesterol From Baseline at Week 12
The study was terminated; no outcome measure data analyses were conducted.
Measured: Baseline and 12 weeks
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment
The study was terminated; no outcome measure data analyses were conducted.
Measured: Baseline and 12 weeks
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment
The study was terminated; no outcome measure data analyses were conducted.
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 20071 Feb 2008

First posted21 Aug 2008 (estimated)
Study start19 Sep 2007
Primary completion1 Feb 2008
Study completion1 Feb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Systemic Lupus ErythematosusStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00739050
Sponsor's protocol ID: 0733-271
Other IDs: 2008_021
Status last verified: Feb 2022
First submitted: 19 Aug 2008
Last updated: 23 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus

All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT00739050
Acronym / sponsor ID: 0733-271
Conditions: Systemic Lupus Erythematosus
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 4 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 19 Sep 2007 (actual)
Primary completion: 1 Feb 2008 (actual)
Study completion: 1 Feb 2008 (actual)
First posted: 21 Aug 2008 (estimated)
Results: Posted 16 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: simvastatinArm 1: Drug
2	Placebo comparator	Drug: Comparator: PlaceboArm 2: Placebo

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Female Patients Over 18 Years Old
Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)
Signed Informed Consent Form (ICF)

Key exclusion criteria (4 listed)

Patients With LDL-C Below 90 mg/dL
Pregnant Or Breast Feeding
Diabetes Mellitus
Or Any Clinically Relevant Organ Disfunction

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
simvastatinAlso: Zocor, MK0733simvastatin 20mg daily at nights for 12 weeks. Tablets	Drug	1
Comparator: Placeboplacebo daily at nights for 12 weeks. Tablets	Drug	2

Primary outcome

Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.
Time frame: Baseline and 12 weeks
The study was terminated; no outcome measure data analyses were conducted.

3 secondary outcomes

Change in Total Cholesterol From Baseline at Week 12
Time frame: Baseline and 12 weeks
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 16 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simvastatin	4	3
Placebo	0	0

Primary outcome: Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.

Time frame: Baseline and 12 weeks

Population analysed: The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simvastatin	0 of 4 (0%)	0 of 4 (0%)	Not reported
Placebo	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): The Investigator was not able to recruit the required patients and was not able to get the necessary equipment. The protocol was terminated for Administrative Reasons.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Systemic Lupus Erythematosus

Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing simvastatin in people with Systemic Lupus Erythematosus, run by Organon and Co.

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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 May 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment. (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00739050.

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 23 May 2024.