Study of LLG783 in patients with peripheral artery disease (PAD) and intermittent claudication.

Phase 1

• Conditions: Peripheral Artery Disease (PAD), Intermittent Claudication; MedDRA version: 20.0Level: PTClassification code 10022562Term: Intermittent claudicationSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0Level: LLTClassification code 10034633Term: Peripheral vascular diseaseSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-000706-37-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Study Completion: 2018-12-27
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Clinical evidence of PAD and intermittent claudication. Intermittent claudication, as defined by pain with exertion in either leg
• On stable medical therapy for PAD and PAD symptoms, which may include statins, aspirin, and antiplatelet medications (as medically indicated) unless individually contraindicated, for at least 4 weeks prior to the screening visit.
• Vital signs must be within the following ranges:
o body temperature between 35.0-37.5°C
o systolic blood pressure, 90-159 mm Hg
o diastolic blood pressure, 50-99 mm Hg
o pulse rate, 50 - 90 bpm
• Moderately impaired ambulatory function judged by the investigator to be due primarily to PAD and assessed by a maximum walk distance between 50 and 400 meters (inclusive of these values) at the screening 6MWT.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• Pregnant or nursing (lactating) women.
• Patients who meet any of the following PAD related criteria:
o Patients actively attending and participating in a supervised exercise rehabilitation program (patients who have already
completed such a program and remain symptomatic may be included).
o Patients with any condition other than PAD that limits walking
ability.
o Known inflammatory disease of the arteries (other than atherosclerosis; e.g. Thromboangiitis obliterans).
o Clinical evidence of critical limb ischemia including new or non-healing ulcers (felt secondary to critical limb ischemia), new or
recent onset of resting pain in the lower extremities particularly at
night (felt secondary to critical limb ischemia) and/or gangrene of
the lower extremities (Fontaine stage III-IV) .
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 150 days after stopping of investigational drug
• Any of the following concomitant cardiovascular or metabolic conditions or diseases:
o Myocardial infarction within 6 months of screening.
o Stroke within 6 months of screening.
o History of clinically significant ventricular arrhythmias, according to
the discretion of the investigator, within 6 months of screening.
o Significant ECG abnormalities, according to the discretion of the
investigator, at screening.
o History of sustained and clinically significant supraventricular
arrhythmias (e. g. associated with hemodynamic compromise)
within 6 months of screening.
o Chronic heart failure New York Heart Association Class III or IV.
o Known presence of aortic aneurysm > 5 cm.
o Uncontrolled diabetes as defined by a random fasting glucose level
of 13 mmol/L or 240 mg/dL or a HbA1c greater than 9% as measured at screening. Diabetes should be treated as appropriate
during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified