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Peripheral Arterial DiseasePhase 2NCT00351286

Efficacy Study of Oral L-Citrulline in Patients Taking Simvastatin With Peripheral Arterial Disease

A Phase 2 study testing L-citrulline tablets, 1000 mg and Background simvastatin at a stable dose of 40 mg qHS in people with Peripheral Arterial Disease and Intermittent Claudication, run by Angiogenix at 10 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To prove the combination of L-citrulline with simvastatin leads to greater improvement in the symptoms of peripheral arterial disease (PAD) than simvastatin alone by evaluating oral L- citrulline or placebo against simvastatin for improvement in treadmill walking distance in patients, 40-75 years of age, who have PAD… Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
L-citrulline tablets, 1000 mg and Background simvastatin at a stable dose of 40 mg qHS
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
10 sitesRussia
Study dates
Mar 2006to not given
Phase
Phase 2
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 40-75 years of age
  • If female, post-menopausal for the past year, surgically sterile (i.e., tubal ligation, hysterectomy), or using an adequate method of birth control (i.e., oral contraceptives, double barrier method, IUD cover, sterilized partner, or other method deemed appropriate by Investigator)
  • If male capable of fathering children, using an adequate method of birth control (i.e., condom or partner using adequate method of birth control)
  • Peripheral arterial disease with stable, reproducible, intermittent claudication and symptom-limited treadmill walking distance of at least 6 months duration
  • Rest ankle-brachial index (ABI) ≤0.90 and 10 mm Hg decrease in ankle pressure 1 minute after completing the ETT
  • ACWD on a standardized (Skinner-Gardner protocol) ETT ≥50 m (164 feet) but ≤300 m (984 feet) determined by the average result on two consecutive ETTs performed at least 7 days apart during the screening phase (Fontaine stage II)
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  • ACWD variability <25% between two consecutive ETTs performed at least 7 days apart during the screening phase. The percent variability is calculated by the difference of the two walking distances divided by the greater of the two walking distances multiplied by 100%. If the variability exceeds 25% a third ETT may be performed and the variability between the second and third test used to determine baseline and inclusion criteria
  • Willingness to receive dietary counseling and follow a low-cholesterol diet during the study
  • Ability to give written informed consent and has signed a written informed consent form approved by the Investigator's Independent Ethics Committee (IEC)

Who cannot join

  • Critical limb ischemia (defined as presence of rest pain requiring analgesics for more than 2 weeks or the presence of lower limb ulcers or gangrene)
  • Coronary artery or peripheral artery angioplasty or surgical limb arterial bypass within the last 3 months
  • Any previous amputation on the lower limbs
  • Anticipated requirement of surgical or percutaneous revascularization within 3 months of randomization
  • Currently participating in a supervised exercise regimen
  • Stroke, myocardial infarction, or deep-vein thrombosis within the last 3 months
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  • Non-atherosclerotic PAD (e.g., thromboangiitis obliterans)
  • Known abdominal aortic aneurysm ≥4.5 cm
  • Unstable angina pectoris within the last 3 months
  • Congestive heart failure (New York Heart Association Class III or IV) despite treatment
  • Severe, uncontrolled hypertension (sitting systolic blood pressure >180 mm Hg or sitting diastolic blood pressure >95 mm Hg)
  • Anemia (hemoglobin <10 g/dL in women and 11 g/dL in men) or any clinically significant bleeding episode within the last year
  • Abnormal platelet count (platelets >150,000/mm3 or <60,000/mm3)
  • Type I diabetes mellitus or Type II diabetes mellitus if it is accompanied by diabetic peripheral neuropathy
  • Morbid obesity (body mass index >40 kg/m2)
  • Severe renal insufficiency (creatinine >221 µmol/L (2.5 mg/dL))
  • Severe hepatic insufficiency (ALT [SGPT] and AST [SGOT] ≥ 3x upper limit of normal on two separate tests
  • Any disorder that would affect the interpretation of ETT results
  • Use of medications that are not allowed and which cannot be discontinued during the study
  • Participation in an investigational drug or device study within previous 30 days
  • Underlying disease other than PAD resulting in a life expectancy of less than 1 year
  • If female, breast feeding, pregnancy confirmed by a positive serum pregnancy test, or using inadequate birth control
  • Other conditions that could impair informed consent or compliance

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Russia10 sites

  • Municipal Healthcare Institution, Gatchina Central District Hospital

    Gatchina, Russia, 188300

  • Russian State Medical University at Filatov City Hospital #15

    Moscow, Russia, 111539

  • Vishnevsky Institute of Surgery, Russian Medical Academy of Science

    Moscow, Russia, 113811

  • Municipal Prophylaxis and Treatment Institution, City Hospital #13

    Nizhny Novgorod, Russia, 603018

  • St. Petersburg State Healthcare Institution, Research for Emergency Medical Care

    Saint Petersburg, Russia, 192242

  • St. Petersburg State Healthcare Institution, Hospital #2

    Saint Petersburg, Russia, 194354

  • St. Petersburg State Healthcare Institution, Hospital #26

    Saint Petersburg, Russia, 196247

  • State Educational Institution of Higher Professional Education

    Saint Petersburg, Russia, 197089

  • St. Petersburg State Healthcare Institution, Pokrovskaya Hospital

    Saint Petersburg, Russia, 199106

  • Municipal Medical Institution City Hospital #1 of Saratov

    Saratov, Russia, 410056

Other trials in Russia

About this study

Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral L-Citrulline Compared to Placebo in Patients Taking Background Simvastatin 40 mg qD and With Peripheral Arterial Disease Including Intermittent Claudication

To prove the combination of L-citrulline with simvastatin leads to greater improvement in the symptoms of peripheral arterial disease (PAD) than simvastatin alone by evaluating oral L- citrulline or placebo against simvastatin for improvement in treadmill walking distance in patients, 40-75 years of age, who have PAD with intermittent claudication.

Read the detailed description

The primary objective of this study is to prove the combination of L-citrulline with simvastatin leads to greater improvement in the symptoms of PAD than simvastatin alone. This will be accomplished by evaluating efficacy of orally administered L-citrulline or placebo against background therapy with simvastatin for improvement in treadmill absolute claudication walking distance (ACWD) in patients, 40-75 years of age, who have PAD with intermittent claudication in Fontaine stage II and symptom-limited treadmill walking distance.

Secondary objectives include comparing the combination therapy to simvastatin alone for improvement in treadmill pain-free walking distance (PFWD) and ischemic window.

Other secondary objectives include evaluating the safety and tolerability of L-citrulline alone or combined with simvastatin in this patient population and assessing the effects of treatment on quality of life (QOL) as measured by two QOL instruments.

Being tested
L-citrulline tablets, 1000 mg, Placebo tablets matching L-citrulline tablets, Background simvastatin at a stable dose of 40 mg qHS
Keywords
peripheral arterial disease, peripheral vascular disease, claudication
Medical subject headings
Peripheral Arterial Disease, Intermittent Claudication, Peripheral Vascular Diseases

What participants receive

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

  • L-citrulline tablets, 1000 mgDrug

  • Placebo tablets matching L-citrulline tabletsDrug

  • Background simvastatin at a stable dose of 40 mg qHSDrug

What is being measured

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

  1. Change in absolute claudication walking distance from baseline to end of 12-week double-blind treatment period.

Secondary outcomes (3)

  1. Change in pain-free walking distance

  2. Changes in QOL scores from baseline to 12 and 36 weeks

  3. Change in absolute claudication walking distance from baseline to 36 weeks

Timeline

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

  1. First posted12 Jul 2006 (estimated)
  2. Study startMar 2006

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
160 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00351286
Sponsor's protocol ID
ANGX-1039-02
Status last verified
Jul 2006
First submitted
10 Jul 2006
Last updated
18 Oct 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing L-citrulline tablets, 1000 mg and Background simvastatin at a stable dose of 40 mg qHS in people with Peripheral Arterial Disease and Intermittent Claudication, run by Angiogenix at 10 sites in Russia.

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 9 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 18 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Russia. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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 in absolute claudication walking distance from baseline to end of 12-week double-blind treatment period.. 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 NCT00351286.

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 18 Oct 2006.

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