Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2018-12-27

Brief Summary

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This study is designed to determine whether LLG783 displays the clinical safety and efficacy profile, after multiple i.v. doses, to support further development in patients with PAD and intermittent claudication.

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Detailed Description

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Conditions

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Peripheral Artery Disease (PAD); Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, patient and investigator-blinded, placebo controlled, parallel group study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LLG783

Patients will receive LLG783 i.v. infusion every 4 weeks for 12 weeks.

Group Type EXPERIMENTAL

LLG783

Intervention Type DRUG

LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.

Placebo

Patients will receive placebo to LLG783 i.v. infusion every 4 weeks for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.

Interventions

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LLG783

LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.

Intervention Type DRUG

Placebo

Placebo to LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* claudication, as defined by pain with exertion in either leg;
* On stable medical therapy, including statins, aspirin, and antihypertensive 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:

* body temperature between 35.0-37.5°C
* systolic blood pressure, 90-159 mm Hg
* diastolic blood pressure, 50-99 mm Hg
* 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 6-minute walk test (6MWT).

Exclusion Criteria

* Pregnant or nursing (lactating) women;
* Patients who meet any of the following PAD related criteria:

* 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).
* Patients with any condition other than PAD that limits walking ability.
* Known inflammatory disease of the arteries (other than atherosclerosis; e.g. Thromboangiitis obliterans).
* 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:

* Myocardial infarction within 6 months of screening.
* Stroke within 6 months of screening.
* History of clinically significant ventricular arrhythmias, according to the discretion of the investigator, within 6 months of screening.
* Significant ECG abnormalities, according to the discretion of the investigator, at screening.
* History of sustained and clinically significant supraventricular arrhythmias (e. g. associated with hemodynamic compromise) within 6 months of screening.
* Chronic heart failure New York Heart Association Class III or IV.
* Known presence of aortic aneurysm \> 5 cm.
* 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No