Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLR325 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| CLR325 | DRUG | CLR325 Concentrate for solution for infusion |
| Placebo | OTHER | Normal saline |
Key Inclusion Criteria: * Male and female patients \>18 years of age * Body weight between 50 kg and 140 kg * Cardiac ejection fraction of ≤ 45% assessed within the last 6 months * For PA catheter cohorts, patients who are planned to have a clinically indicated pulmonary artery catheter in place pr...
CLR325 is an investigational small molecule being studied for the treatment of chronic stable heart failure. It is a cardiovascular therapy that has completed a Phase 2 clinical trial. The drug is not approved and remains in clinical development.
CLR325 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company conducted a Phase 2 clinical trial of the drug in patients with chronic stable heart failure.
CLR325 is in Phase 2 clinical development. A Phase 2 trial of the drug in chronic stable heart failure patients has been completed. The drug is investigational and has not been approved by regulatory authorities.
CLR325 has one completed Phase 2 clinical trial, identified as NCT02696967. This randomized, double-blind, placebo-controlled study enrolled 26 patients with chronic stable heart failure across the United States, Belgium, Germany, Netherlands, and Singapore.
CLR325 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for chronic stable heart failure. The drug remains in clinical development and has not received marketing authorization.