Clinical trial NCT01131013 (phase 2, status: completed)
Conditions: intermittent claudication, peripheral artery disease
ICD codes: I70.211, I70.212, I70.213, I70.218, I70.219, I70.611, I70.612, A18.2, H11.043, H11.053, H18.463, H35.40, H81.393, I73.9
Drugs: placebo, 375 mg ck-2017357, 500 mg ck-2017357
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CCC(CC)N1C(=O)NC2=NC=C(N=C12)C#C, CCC(CC)N1C(=O)NC2=NC=C(N=C12)C#C
Eligibility criteria:

        Inclusion Criteria:

          1. Ability to comprehend and willing to sign an Informed Consent Form (ICF)

          2. Ability to understand written and oral English language

          3. 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

          4. Stable claudication symptoms over past 6 months (Fontaine Stage II) in at least one
             calf muscle due to documented peripheral artery disease

          5. Females (of non-childbearing potential) or males who are 40 years of age or older

          6. Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive

          7. Ability to perform the bilateral heel raise familiarization sufficient to induce
             typical claudication at a contraction frequency of once every other second

          8. Ability to complete a six-minute walking test

          9. 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

         10. 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

        Exclusion Criteria:

          1. Asymptomatic peripheral artery disease classified as Fontaine Stage I

          2. Critical leg ischemia classified as Fontaine Stage III-IV (rest pain, tissue necrosis
             or gangrene)

          3. Non-atherosclerotic causes of arterial occlusive disease

          4. "Atypical leg pain," defined as significant residual leg discomfort at rest

          5. Leg, hip, or knee surgery within 6 months prior to randomization

          6. Any revascularization procedure (coronary or peripheral) within 3 months prior to
             randomization

          7. Life-threatening ventricular arrhythmias, unstable angina, stroke, and/or myocardial
             infarction within 3 months prior to randomization

          8. 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

          9. Severe COPD or other respiratory impairment defined as receiving supplemental oxygen
             therapy at home or by clinical assessment of the Investigator

         10. Poorly controlled hypertension (defined as supine resting BP >180 mmHg systolic or >
             100 mmHg diastolic, or both)

         11. Hypotension (defined as supine resting BP < 95 mmHg systolic or < 55 mmHg diastolic,
             or both, or symptomatic hypotension [standing, supine, or orthostatic])

         12. 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

         13. Type 1 diabetes (juvenile onset, insulin-dependent), or poorly controlled Type 2
             diabetes (defined as HbA1c > 9.0% in the past 3 months)

         14. Hepatic insufficiency (defined as ALT or AST > 3x ULN, or total bilirubin > 3 mg/dL)

         15. Renal insufficiency (defined as serum creatinine > 2.5 mg/dL or receiving dialysis)

         16. Anemia (defined as hemoglobin < 12.0 g/dL)

         17. 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

         18. Previous treatment with gene therapy or other vascular endothelial growth factor
             (VEGF)-related therapy

         19. Any prior treatment with CK-2017357

         20. 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