A Study of CK-2017357 in Patients With Peripheral Artery Disease and Symptomatic Claudication

Completed · Phase 2 · Has a placebo group

Conditions studied: Intermittent Claudication, Peripheral Artery Disease

In brief

The primary objective of this early-stage clinical study is to demonstrate an effect of single doses of CK-2017357 on measures of skeletal muscle function and fatigability in patients with peripheral artery disease and symptomatic claudication.

Key facts

Study ID

NCT01131013

Run by

Cytokinetics

People needed

61

Starts

2010-05-01

Expected to finish

2011-03-01

Last updated by the study team

2019-05-14

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to comprehend and willing to sign an Informed Consent Form (ICF)
• Ability to understand written and oral English language
• Peripheral arterial disease defined as an ankle-brachial index (ABI) at rest ≤ 0.90 in at least one leg in which the patient experiences claudication
• Stable claudication symptoms over past 6 months (Fontaine Stage II) in at least one calf muscle due to documented peripheral artery disease
• Females (of non-childbearing potential) or males who are 40 years of age or older
• Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
• Ability to perform the bilateral heel raise familiarization sufficient to induce typical claudication at a contraction frequency of once every other second
• Ability to complete a six-minute walking test
• Pre-study clinical laboratory findings (including troponin I [TnI] and creatine phosphokinase [CPK]) within the normal range, or if outside of the normal range, deemed not clinically significant by the Investigator and Sponsor's Medical Monitor
• For female patients only: Non-childbearing potential (e.g., documented post-menopausal ≥ 1 year, sterilized, status-post hysterectomy) For male patients only: Agreement either
• To use a condom during sexual intercourse with female partners who are of reproductive potential and to have female partners use an additional effective means of contraception (e.g., diaphragm plus spermicide, or oral contraceptives) for the duration of the study and 10 weeks after the end of the study or
• To abstain from sexual intercourse for the duration of the study and 10 weeks after the end of the study

You may not qualify if…

• Asymptomatic peripheral artery disease classified as Fontaine Stage I
• Critical leg ischemia classified as Fontaine Stage III-IV (rest pain, tissue necrosis or gangrene)
• Non-atherosclerotic causes of arterial occlusive disease
• "Atypical leg pain," defined as significant residual leg discomfort at rest
• Leg, hip, or knee surgery within 6 months prior to randomization
• Any revascularization procedure (coronary or peripheral) within 3 months prior to randomization
• Life-threatening ventricular arrhythmias, unstable angina, stroke, and/or myocardial infarction within 3 months prior to randomization
• Moderate/severe symptomatic heart failure defined as NYHA Class III or IV; in patients with NYHA Class I or II heart failure, the screening heel raise familiarization must elicit claudication symptoms and not cardiac symptoms
• Severe COPD or other respiratory impairment defined as receiving supplemental oxygen therapy at home or by clinical assessment of the Investigator
• Poorly controlled hypertension (defined as supine resting BP >180 mmHg systolic or > 100 mmHg diastolic, or both)
• Hypotension (defined as supine resting BP < 95 mmHg systolic or < 55 mmHg diastolic, or both, or symptomatic hypotension [standing, supine, or orthostatic])
• Exercise tolerance (including ability to perform heel raise and six-minute walk test) that, in the opinion of the Investigator, is significantly limited by other co-morbid conditions or diseases other than claudication
• Type 1 diabetes (juvenile onset, insulin-dependent), or poorly controlled Type 2 diabetes (defined as HbA1c > 9.0% in the past 3 months)
• Hepatic insufficiency (defined as ALT or AST > 3x ULN, or total bilirubin > 3 mg/dL)
• Renal insufficiency (defined as serum creatinine > 2.5 mg/dL or receiving dialysis)
• Anemia (defined as hemoglobin < 12.0 g/dL)
• Participation in any other investigational study drug or device trial in which receipt of an investigational study drug or device occurred within 30 days prior to dosing
• Previous treatment with gene therapy or other vascular endothelial growth factor (VEGF)-related therapy
• Any prior treatment with CK-2017357
• Recent history of alcoholism or drug abuse, or significant behavioral or psychiatric problems, or other conditions which in the Investigator's opinion may impair ability to adequately comply with the requirements of the study

Where it is running

• Tatum Ridge Internal Medicine — Phoenix, Arizona, United States
• Apex Research Institute — Santa Ana, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Tampa Bay Medical Research — Clearwater, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• DMI Research, Inc — Pinellas Park, Florida, United States
• Maine Research Associates — Auburn, Maine, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Baylor College of Medicine — Houston, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• National Clinical Research - Norfolk, Inc. — Norfolk, Virginia, United States
• National Clinical Research - Richmond, Inc. — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.