Clinical Trial News

Drugs

PROVIDENCE-1 is a phase III interventional study to determine whether the drug rifalazil can significantly increase peak walking time (PWT) in patients with peripheral arterial disease who are also seropositive for Chlamydia pneumoniae.

The primary outcome is change from baseline in PWT, with safety end points being the rates of adverse events, vascular death, MI, stroke, clinically significant laboratory abnormalities, and physical exam abnormalities; vital signs; and the need for revascularization procedures. The study, sponsored by ActivBiotics, started in November 2005, has an expected completion date of December 2007, and plans to enroll 120 patients.

Resistance to Aspirin and/or Clopidogrel Among Patients with PAD is a phase IV interventional, diagnostic, nonrandomized, open-label, uncontrolled trial to determine the prevalence and prognostic significance of aspirin resistance in patients with atherosclerosis of the lower limbs.

Because such patients are at high risk of heart attack and stroke, the primary outcomes are myocardial infarction, unstable angina, cerebral infarction, transitory cerebral ischemia, percutaneous or surgical vascular intervention, sudden deterioration of symptoms, amputation, and death.

The main objectives are to measure the activity of platelets during aspirin treatment and a minor population of patients taking clopidogrel. The secondary objective is to describe the relation between drug resistance and the level of inflammatory markers in the blood. The study, sponsored by Aalborg (Denmark) Hospital, started in September 2005, and plans to enroll 1,000 patients with a 6-year follow-up.

Odiparcil for the Prevention of Venous Thromboembolism is a phase II interventional, dose-ranging study to determine whether the drug odiparcil can prevent blood clots from forming after a total knee replacement. It is a randomized, active-control trial comparison with warfarin. The primary outcome is the total venous thromboembolism (VTE) event rate after 8-12 days of dosing. The secondary outcomes are relative risk of VTE at day 10; VTE event rate for odiparcil at day 10; pharmacodynamic effect as measured by anti-IIa activity at days 1, 3, 5, and 10; results of liver function tests; and major bleeding at any time during the trial.

The study, sponsored by GlaxoSmithKline, started in September 2005 and plans to enroll 915 patients.

ICXP007 with Compression Bandaging for Treatment of Noninfected Venous Leg Ulcers is a phase III interventional study seeking to evaluate the safety and efficacy of using active, allogeneic human dermal fibroblasts presented in a fibrin matrix, in combination with four-layer therapeutic compression applied to venous leg ulcers of at least 3 months' duration that have not responded to conventional therapy.

The primary outcome of the multicenter, randomized, placebo-controlled study is the incidence of 100% closure (epithelization) at any time during the initial 12 weeks of the treatment period.

The secondary outcomes include the overall rate of wound area reduction during treatment, time to first closure, qualitative wound pain, appearance of a new ulcer in the target wound area post closure, and incidence of reopening and/or reclosure at 16, 20, and 24 weeks. The study, which began in July 2005, is sponsored by Intercytex and expects to enroll 216 patients.

Devices

DynaCT: Evaluation of Image Quality is a study designed to evaluate CT-like imaging during intraoperative procedures--specifically, the implementing of a stent graft in an abdominal aortic aneurysm.

This interventional, nonrandomized study will evaluate image quality as its primary outcome, by comparing imaging with the DynaCT with the current standard modality (multidetector CT) during the endovascular treatment of abdominal aortic aneurysms.

Investigators in the study, which is sponsored by the Norwegian University of Science and Technology and St. Olav's Hospital, Trondheim, expect to enroll 20 patients.

--From staff reports