Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000706-37 | EudraCT Number |
Not provided
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LLG783 | Experimental | Patients will receive LLG783 i.v. infusion every 4 weeks for 12 weeks. |
|
| Placebo | Placebo Comparator | Patients will receive placebo to LLG783 i.v. infusion every 4 weeks for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLG783 | Drug | LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) |
Not provided
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:
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:
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:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Jacksonville | Florida | 32216 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
Not provided
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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A total of 46 subjects with clinical evidence of PAD and intermittent claudication were enrolled and randomized in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | LLG783 6mg/kg | Participants received LLG783 6 milligram per kilogram (mg/kg) as intravenous (IV) infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2017 | Dec 16, 2019 |
Not provided
Randomized, patient and investigator-blinded, placebo controlled, parallel group study
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Not provided
Not provided
| Placebo | Drug | Placebo to LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| Columbus |
| Ohio |
| 43215 |
| United States |
| Novartis Investigative Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Berlin | 10787 | Germany |
| Novartis Investigative Site | Magdeburg | 39112 | Germany |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | 11217 | Taiwan |
Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LLG783 6mg/kg | Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks. |
| BG001 | Placebo | Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Maximum walking distance (MWD) | MWD was determined by 6-minute walking test (6-MWT), an exercise test measuring the distance walked by a participant over a span of 6 minutes. | Mean | Standard Deviation | meters |
| ||||||||||||||
| Pain Free Walking Distance (PWFD) | PWFD was defined as the distance walked up to the point of onset of claudication symptoms (pain) recorded during the 6MWT. | Mean | Standard Deviation | meters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set included all participants that received any study treatment. | Posted | Count of Participants | Participants | 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. | Pharmacodynamic (PD) analysis set included all participants with available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this endpoint. | Posted | Least Squares Mean | 80% Confidence Interval | meter (m) | 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. | PK analysis set: Participants with at least 1 available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data. N (overall number of participants analyzed) = participants evaluable for this outcome measure and 'n' (number analyzed) = participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*microgram per millileter (day*mg/mL) | 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. | Pharmacokinetic (PK) analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*mcg/mL | 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. | PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*mcg/mL | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*mcg/mL | 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. | PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | 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. | PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data. | Posted | Median | Full Range | Days | 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. | PD analysis set included all participants with available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 80% Confidence Interval | meters | Baseline, Week 16 (Day 113) |
|
Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LLG783 i.v. 6 mg/kg | Participants received LLG783 6 mg/kg as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks. | 0 | 23 | 1 | 23 | 18 | 23 |
| EG001 | Placebo | Participants received placebo as IV infusion once every 4 weeks for a total of 4 doses over a period of 12 weeks. | 0 | 23 | 2 | 23 | 16 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Medical device site irritation | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Infected bite | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Root canal infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (21.1) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Spider vein | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2019 | Dec 16, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| SAEs |
|
| Death |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|