Peripheral Artery Disease (PAD); Intermittent ClaudicationPhase 2PAD PoCNCT03194776
Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
A Phase 2 study testing LLG783 in people with Peripheral Artery Disease (PAD); Intermittent Claudication, run by Novartis Pharmaceuticals at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Peripheral Artery Disease (PAD); Intermittent Claudication
- What is being tested?
- LLG783
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 20 Sep 2017to 27 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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) .
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- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany4 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Kiel, Schleswig-Holstein, 24105
Novartis Investigative Site
Magdeburg, 39112
United States2 sites
Novartis Investigative Site
Columbus, Ohio, 43215
Novartis Investigative Site
Jacksonville, Florida, 32216
Taiwan2 sites
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 11217
About this study
Official title: A Patient and Investigator-blinded, Randomized, Placebo Controlled Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
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.
- Being tested
- LLG783, Placebo
- Keywords
- PAD, peripheral artery/arterial disease, peripheral vascular disease, leg pain, claudication, leg pain with exercise, exercise test, walk test
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| LLG783 | Experimental | Patients will receive LLG783 i.v. infusion every 4 weeks for 12 weeks. Receives: Drug: LLG783 |
| Placebo | Placebo comparator | Patients will receive placebo to LLG783 i.v. infusion every 4 weeks for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign, including abnormal laboratory findings, symptom or disease) in a participant after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any AE which is is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect in offspring, requires inpatient hospitalization or prolongation of existing hospitalization and is is medically significant.
Measured: Up to 32 Weeks
Change From Baseline in Maximum Walking Distance (MWD) as Assessed by 6-minute Walk Test (6MWT) at Week 16
MWD was assessed by the 6MWT prior to dosing was used to evaluate functional capacity of peripheral artery disease (PAD) participants. 6MWT test included measurement of total distance walked in 6 minutes.
Measured: Baseline, Week 16 (Day 113)
Secondary outcomes (7)
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)
AUCinf is defined as the area under the serum concentration-time curve from time zero to infinity.
Measured: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
AUClast is defined as the area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration.
Measured: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point 't' (AUC[0-t])
AUC(0-t)is defined as the area under the serum concentration-time curve from time zero to time 't' where is a defined time point after administration.
Measured: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)
AUCtau is defined as the area under the serum concentration-time curve from time zero to the end of the dosing interval tau.
Measured: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Observed Maximum Serum Concentration (Cmax) Following Drug Administration
Cmax is defined as the observed maximum serum concentration following drug administration.
Measured: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Tmax is defined as the time to reach the maximum concentration after drug administration.
Measured: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Change From Baseline in Pain-free Walking Distance (PFWD) as Assessed by 6-minute Walk Test at Week 16
PFWD was defined as the distance walked up to the point of onset of claudication symptoms (pain) recorded during the 6MWT and was used to evaluate symptomatic functional capacity of PAD participants. The PFWD was measured as the distance walked up to the time/place where the participant first experiences symptoms typical of their claudication which included pain, cramps, or other discomfort in the buttocks, thighs, calves or feet that occurs during the 6MWT exercise period.
Measured: Baseline, Week 16 (Day 113)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start20 Sep 2017
- Primary completion7 Sep 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery Disease (PAD); Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, patient and investigator-blinded, placebo controlled, parallel group study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194776
- Sponsor's protocol ID
- CLLG783X2201
- Other IDs
- 2017-000706-37, 2017
- Acronym
- PAD PoC
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2017
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient and Investigator-blinded, Randomized, Placebo Controlled Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
- ClinicalTrials.gov ID
- NCT03194776
- Acronym / sponsor ID
- PAD PoC / CLLG783X2201
- Keywords
- PAD, peripheral artery/arterial disease, peripheral vascular disease, leg pain, claudication, leg pain with exercise, exercise test, walk test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 7 Sep 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, patient and investigator-blinded, placebo controlled, parallel group study
| Arm | Type | Receives |
|---|---|---|
| LLG783 | Experimental | Drug: LLG783Patients will receive LLG783 i.v. infusion every 4 weeks for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo to LLG783 i.v. infusion every 4 weeks for 12 weeks. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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).
Key exclusion criteria (16 listed)
- Pregnant or nursing (lactating) women;
- Patients who meet any of the following PAD related criteria:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLG783LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration. | Drug | LLG783 |
| PlaceboPlacebo to LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration. | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths
Time frame: Up to 32 Weeks
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign, including abnormal laboratory findings, symptom or disease) in a participant after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any AE which is is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect in offspring, requires inpatient hospitalization or prolongation of existing hospitalization and is is medically significant.
Change From Baseline in Maximum Walking Distance (MWD) as Assessed by 6-minute Walk Test (6MWT) at Week 16
Time frame: Baseline, Week 16 (Day 113)
MWD was assessed by the 6MWT prior to dosing was used to evaluate functional capacity of peripheral artery disease (PAD) participants. 6MWT test included measurement of total distance walked in 6 minutes.
7 secondary outcomes
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Time frame: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point 't' (AUC[0-t])
Time frame: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)
Time frame: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Observed Maximum Serum Concentration (Cmax) Following Drug Administration
Time frame: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Time frame: 1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85
Change From Baseline in Pain-free Walking Distance (PFWD) as Assessed by 6-minute Walk Test at Week 16
Time frame: Baseline, Week 16 (Day 113)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LLG783 in people with Peripheral Artery Disease (PAD); Intermittent Claudication, run by Novartis Pharmaceuticals at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths (time frame: Up to 32 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.