Peripheral Artery Disease (PAD); Intermittent Claudication Clinical Trial
— PAD PoCOfficial title:
A Patient and Investigator-blinded, Randomized, Placebo Controlled Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
| Verified date | March 2020 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | December 27, 2018 |
| Est. primary completion date | September 7, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 85 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Kiel | Schleswig-Holstein |
| Germany | Novartis Investigative Site | Magdeburg | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Taiwan | Novartis Investigative Site | Taipei | |
| United States | Novartis Investigative Site | Columbus | Ohio |
| United States | Novartis Investigative Site | Jacksonville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Germany, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 32 Weeks | |
| Primary | 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. | Baseline, Week 16 (Day 113) | |
| Secondary | 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. | 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 | |
| Secondary | 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. | 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 | |
| Secondary | 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. | 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 | |
| Secondary | 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. | 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 | |
| Secondary | Observed Maximum Serum Concentration (Cmax) Following Drug Administration | Cmax is defined as the observed maximum serum concentration following drug administration. | 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 | |
| Secondary | Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Tmax is defined as the time to reach the maximum concentration after drug administration. | 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 | |
| Secondary | 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. | Baseline, Week 16 (Day 113) |