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Trial record 4 of 25 for:    Recruiting, Not yet recruiting, Available Studies | "Intermittent Claudication"

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

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ClinicalTrials.gov Identifier: NCT03194776
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease (PAD); Intermittent Claudication Drug: LLG783 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, patient and investigator-blinded, placebo controlled, parallel group study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Patient and Investigator-blinded, Randomized, Placebo Controlled Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : December 29, 2018
Estimated Study Completion Date : December 29, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: LLG783
Patients will receive LLG783 i.v. infusion every 4 weeks for 12 weeks.
Drug: LLG783
LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.
Placebo Comparator: Placebo
Patients will receive placebo to LLG783 i.v. infusion every 4 weeks for 12 weeks.
Drug: Placebo
Placebo to LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.



Primary Outcome Measures :
  1. Number of patients reported with any adverse events, serious adverse events and death [ Time Frame: 32 weeks (225 days) ]
  2. Change from baseline in maximum walking distance (MWD) [ Time Frame: Baseline, 16 weeks (113 days) ]
    Maximum walking distance as assessed by 6-minute walk test


Secondary Outcome Measures :
  1. Pharmacokinetics of LLG783: The area under the concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: 1 hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 1; 0 hour pre-dose on Day 29 and Day 57; ) hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 85 ]
  2. Pharmacokinetics of LLG783: The area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [ Time Frame: 1 hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 1; 0 hour pre-dose on Day 29 and Day 57; ) hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 85 ]
  3. Pharmacokinetics of LLG783: The area under the concentration-time curve from time zero to time "t" where t is defined as the time point after administration (AUC0-t) [ Time Frame: 1 hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 1; 0 hour pre-dose on Day 29 and Day 57; ) hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 85 ]
  4. Pharmacokinetics of LLG783: The area under the concentration-time curve over a dosing interval (AUCtau) [ Time Frame: 1 hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 1; 0 hour pre-dose on Day 29 and Day 57; ) hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 85 ]
  5. Pharmacokinetics of LLG783: The observed maximum concentration following drug administration (Cmax) [ Time Frame: 1 hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 1; 0 hour pre-dose on Day 29 and Day 57; ) hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 85 ]
  6. Pharmacokinetics of LLG783: The time to reach the maximum concentration after drug administration (Tmax) [ Time Frame: 1 hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 1; 0 hour pre-dose on Day 29 and Day 57; ) hour pre-dose and 1 hour, 2 hour, 4 hour post-dose on Day 85 ]
  7. Change from baseline in pain-free walking distance [ Time Frame: Baseline, 16 weeks (113 days) ]
    Pain-free walking distance as assessed by 6-minute walk test



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194776


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
United States, Florida
Novartis Investigative Site Recruiting
Jacksonville, Florida, United States, 32216
United States, Ohio
Novartis Investigative Site Recruiting
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03194776     History of Changes
Other Study ID Numbers: CLLG783X2201
2017-000706-37 ( EudraCT Number )
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
PAD
peripheral artery/arterial disease
peripheral vascular disease
leg pain
claudication
leg pain with exercise
exercise test
walk test

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis
Peripheral Vascular Diseases