CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
LLG783 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Claudication pain with exertion in either leg
  • ✓On stable medical therapy (statins, aspirin, antihypertensive medications) for at least 4 weeks prior to screening
  • ✓Vital signs within normal ranges: temperature 35.0-37.5°C, systolic BP 90-159 mmHg, diastolic BP 50-99 mmHg, pulse 50-90 bpm
  • ✓Maximum walk distance 50-400 meters on 6-minute walk test at screening, with ambulatory limitation judged primarily due to PAD
Key exclusion· 13
  • ✕Pregnant or nursing women
  • ✕Women of childbearing potential unless using highly effective contraception during dosing and for 150 days after stopping investigational drug
  • ✕Myocardial infarction within 6 months of screening
  • ✕Stroke within 6 months of screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03194776
NCT03194776Phase 2Completed
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A Patient and Investigator-blinded, Randomized, Placebo Controlled Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication

Novartis Pharmaceuticals·interventional·Posted Jun 21, 2017·Updated Jan 5, 2021

In Brief

A Phase 2 clinical trial evaluating LLG783 and Placebo for Peripheral Artery Disease (PAD); Intermittent Claudication. Completed, enrolled 46 participants across 8 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease (PAD); Intermittent Claudication
CountriesGermany, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 21, 2017
Enrollment StartSep 20, 2017
Primary CompletionSep 7, 2018
Study CompletionDec 27, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 9.0 years ago

Interventions

LLG783drug

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

Placebodrug

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