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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001387-12 | EudraCT Number |
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The purpose of this study was to determine the safety and tolerability of CLR325 intravenous (i.v.) infusion in patients with stable heart failure to determine if further clinical development of the drug in this indication was warranted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLR325 | Experimental | Patients were assigned to one of the 2 treatment arms in fixed randomization ratio. Patients randomized to this arm received single dose of CLR325 (i.v.) in double blind manner. |
|
| Placebo | Placebo Comparator | Patients were assigned to one of the 2 treatment arms in fixed randomization ratio. Patients randomized to this arm received single dose of placebo (i.v.) in double blind manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLR325 | Drug | CLR325 Concentrate for solution for infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events, Serious Adverse Events and Death | Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) in each treatment arm to demonstrate that CLR325 is safe for the treatment of chronic stable heart-failure patients through the monitoring of relevant clinical and laboratory safety parameters. | Day 1 to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to 18 Hours (AUC0-18hr) | AUC0-18hr is the area under the plasma concentration-time curve from time zero to 18 hours after the start of CLR325 infusion. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | 0, 0.5, 3, 5, 8, 10, 12, and 18 hours post start of CLR325 infusion on Day 1 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Impaired renal function as indicated by clinically significant abnormal creatinine values (Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 calculated using the Modification of Diet in Renal Disease Study (MDRD) equation)
History of chronic hepatitis of any non-cardiac etiology
History of any active or clinically significant cardiac tachyarrhythmia (such as recurrent atrial fibrillation with rapid ventricular response within the last year) and patients with chronic atrial fibrillation with a pulse rate ≤ 100 bpm
Patients who received an i.v. infusion of a cardiac inotrope (e.g., dobutamine or milrinone) in the last 24 h prior to randomization
Patients with any significant change in their dose of their ACE, ARB, mineralocorticoid receptor antagonist, diuretic, or β-blocker within the last 12 h
Patients with known significant valvular heart diseases indicated by the following:
History of acute coronary syndrome within the last 60 days as determined by both clinical and enzymatic criteria
For echocardiography-based cohorts only, patients admitted to an inpatient setting for acute decompensated heart failure within the last 30 days
For PA catheter cohorts, patients with a pulmonary capillary wedge pressure of <10 mm Hg at Baseline. For echocardiographic cohorts, patients with a lateral E/E' ratio of < 7 on their baseline echocardiogram. For patients in whom a lateral E/E' ratio cannot be determined (e.g., patients in atrial fibrillation), a central venous pressure of < 5 mm Hg on baseline echocardiogram as determined by inferior vena cava criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chicago | Illinois | 60611 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
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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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Patients were assigned to one of the 2 treatment arms in fixed randomization ratio (CLR325: Placebo):
This study was conducted in 11 centers in 5 countries: Belgium (1), Germany (2), Netherlands (1), Singapore (1) and USA (6).
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| ID | Title | Description |
|---|---|---|
| FG000 | CLR325 0.25 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 0.25 mcg/kg/min (i.v.) in double blind manner. |
| FG001 | CLR325 2.5 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 2.5 mcg/kg/min (i.v.) in double blind manner. |
| FG002 | CLR325 8 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 8 mcg/kg/min (i.v.) in double blind manner. |
| FG003 | Placebo | Patients randomized to this arm received single dose of Placebo (i.v.) in double blind manner. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CLR325 0.25 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 0.25 mcg/kg/min (i.v.) in double blind manner. |
| BG001 | CLR325 2.5 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 2.5 mcg/kg/min (i.v.) in double blind manner. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Patients With Adverse Events, Serious Adverse Events and Death | Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) in each treatment arm to demonstrate that CLR325 is safe for the treatment of chronic stable heart-failure patients through the monitoring of relevant clinical and laboratory safety parameters. | The Safety population, which consisted of all patients who had been exposed to at least one infusion of study drug or placebo, was considered. | Posted | Count of Participants | Participants | Day 1 to 28 |
|
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 1 month.
All randomized patients received a single i.v. infusion of CLR325 or placebo for approximately 18 hours.
Any sign or symptom that occurs during the study treatment and 30 days post-treatment follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CLR325 0.25 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 0.25 mcg/kg/min (i.v.) in double blind manner. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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 | Aug 27, 2018 | Jan 10, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2019 | Jan 10, 2020 | SAP_001.pdf |
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| Other |
Normal saline |
|
| Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From From Time Zero to 28 Hours (AUC0-28hrs) | AUC0-28hr is the area under the plasma concentration-time curve from time zero to 28 hours after the start of CLR325 infusion. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
| Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) | AUCinf is the area under the plasma concentration-time curve from time zero to infinity. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
| Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | AUClast is the area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
| Pharmacokinetic of CLR325: Clearance From Plasma (CL) Following Drug Administration | CL is the systemic (or total body) clearance from plasma following CLR325 infusion. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
| Pharmacokinetic of CLR325 and CQJ295: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) | Cmax,ss is the observed maximum plasma concentration following drug administration at steady state. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
| Pharmacokinetic of CLR325 and CQJ295: Terminal Elimination Half-life (T1/2) | T^1/2 is the elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
| Pharmacokinetic of CLR325 and CQJ295: Time to Reach the Maximum Concentration After Drug Administration (TMax) | Tmax is the time to reach maximum plasma concentration after single dose administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
| Pharmacokinetic of CLR325: Volume of Distribution at Steady State Following Intravenous Administration (Vss) | Vss is the volume of distribution at steady state following intravenous administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
| Pharmacokinetic of CLR325 and CQJ295: Amount of Drug (or Defined Metabolite) Excreted Into the Urine From Time (Ae 0-28 Hours) | Ae 0-28 hours is the amount of drug (or defined metabolite) excreted into the urine from time zero to 28 hours after the start of CLR325 infusion. The urine PK parameters were measured using an non-compartmental methods. Only descriptive analysis performed. | 0-28 hours on Day 1 |
| Pharmacokinetic of CLR325 and CQJ295: Renal Clearance From Plasma (CLr) Following Drug Administration | CLr is the renal clearance from urine following CLR325 infusion. The urine PK parameters were measured using an non-compartmental methods. Only descriptive analysis performed. | 0-28 hours on Day 1 |
| Number of Patients With Increase in Anti-CLR325 and Anti-apelin Antibodies in Serum | Anti-CLR325 anti-apelin antibodies in serum were analyzed predose, Day 10 and Day 28 to determine the immunogenicity of an 18-hour i.v. infusion of CLR325 in heart failure patients. | Baseline (BL), Day 10 (D10) and Day 28 (D28) |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Novartis Investigative Site | Cleveland | Ohio | 44195 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Tacoma | Washington | 98405 | United States |
| Novartis Investigative Site | Aalst | 9300 | Belgium |
| Novartis Investigative Site | Regensburg | Bavaria | 93053 | Germany |
| Novartis Investigative Site | Greifswald | 17475 | Germany |
| Novartis Investigative Site | Amsterdam | 1081 HV | Netherlands |
| Novartis Investigative Site | Singapore | 169609 | Singapore |
| BG002 | CLR325 8 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 8 mcg/kg/min (i.v.) in double blind manner. |
| BG003 | Placebo | Patients randomized to this arm received single dose of Placebo (i.v.) in double blind manner. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| CLR325 2.5 mcg/kg/Min |
Patients randomized to this arm received single dose of CLR325 2.5 mcg/kg/min (i.v.) in double blind manner. |
| OG002 | CLR325 8 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 8 mcg/kg/min (i.v.) in double blind manner. |
| OG003 | Placebo | Patients randomized to this arm received single dose of Placebo (i.v.) in double blind manner. |
|
|
| Secondary | Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to 18 Hours (AUC0-18hr) | AUC0-18hr is the area under the plasma concentration-time curve from time zero to 18 hours after the start of CLR325 infusion. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0, 0.5, 3, 5, 8, 10, 12, and 18 hours post start of CLR325 infusion on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From From Time Zero to 28 Hours (AUC0-28hrs) | AUC0-28hr is the area under the plasma concentration-time curve from time zero to 28 hours after the start of CLR325 infusion. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) | AUCinf is the area under the plasma concentration-time curve from time zero to infinity. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) | AUClast is the area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325: Clearance From Plasma (CL) Following Drug Administration | CL is the systemic (or total body) clearance from plasma following CLR325 infusion. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325 and CQJ295: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) | Cmax,ss is the observed maximum plasma concentration following drug administration at steady state. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325 and CQJ295: Terminal Elimination Half-life (T1/2) | T^1/2 is the elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Mean | Standard Deviation | hr | 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325 and CQJ295: Time to Reach the Maximum Concentration After Drug Administration (TMax) | Tmax is the time to reach maximum plasma concentration after single dose administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Median | Full Range | hr | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325: Volume of Distribution at Steady State Following Intravenous Administration (Vss) | Vss is the volume of distribution at steady state following intravenous administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL | 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325 and CQJ295: Amount of Drug (or Defined Metabolite) Excreted Into the Urine From Time (Ae 0-28 Hours) | Ae 0-28 hours is the amount of drug (or defined metabolite) excreted into the urine from time zero to 28 hours after the start of CLR325 infusion. The urine PK parameters were measured using an non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng | 0-28 hours on Day 1 |
|
|
|
| Secondary | Pharmacokinetic of CLR325 and CQJ295: Renal Clearance From Plasma (CLr) Following Drug Administration | CLr is the renal clearance from urine following CLR325 infusion. The urine PK parameters were measured using an non-compartmental methods. Only descriptive analysis performed. | Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr | 0-28 hours on Day 1 |
|
|
|
| Secondary | Number of Patients With Increase in Anti-CLR325 and Anti-apelin Antibodies in Serum | Anti-CLR325 anti-apelin antibodies in serum were analyzed predose, Day 10 and Day 28 to determine the immunogenicity of an 18-hour i.v. infusion of CLR325 in heart failure patients. | The Safety population, which consisted of all patients who had been exposed to at least one infusion of study drug or placebo, was considered. Only subjest with or without anitbody detected were included in the analysis. | Posted | Count of Participants | Participants | Baseline (BL), Day 10 (D10) and Day 28 (D28) |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | CLR325 2.5 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 2.5 mcg/kg/min (i.v.) in double blind manner. | 0 | 6 | 2 | 6 | 2 | 6 |
| EG002 | CLR325 8 mcg/kg/Min | Patients randomized to this arm received single dose of CLR325 8 mcg/kg/min (i.v.) in double blind manner. | 0 | 6 | 2 | 6 | 4 | 6 |
| EG003 | Placebo | Patients randomized to this arm received single dose of Placebo (i.v.) in double blind manner. | 0 | 10 | 0 | 10 | 7 | 10 |
| Cardiac failure congestive | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Infusion site pruritus | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (21.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Pulmonary arterial wedge pressure decreased | Investigations | MedDRA (21.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
| Hypotension | 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 the pooled data (ie, data from all sites) in the clinical trial.
|
|
| CQJ295 |
|
|
| CQJ295 |
|
|
|
| CQJ295 |
|
|
|
| CQJ295 |
|
|
| CQJ295 |
|
|
|
| BL anti-CLR325 antibody |
|
|
| D10 anti-Apelin antibody |
|
|
| D10 anti-CLR325 antibody |
|
|
| D28 anti-Apelin antibody |
|
|
| D28 anti-CLR325 antibody |
|
|
| Antibody detected = No |
|
| Antibody detected = No |
|
| Antibody detected = No |
|
| Antibody detected = No |
|
| Antibody detected = No |
|