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A Study of CLR325 in Chronic Stable Heart Failure Patients.
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of clr325 infusion on day 1
Summary
This trial tested the safety and tolerability of a drug called CLR325, which is given directly into the bloodstream. The study focused on patients with stable heart failure to see if the drug could be safely used in this group. The goal was to determine if further research on CLR325 for heart failure is needed.
Eligible Conditions
- Chronic Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of clr325 infusion on day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of clr325 infusion on day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients With Adverse Events, Serious Adverse Events and Death
Secondary study objectives
Number of Patients With Increase in Anti-CLR325 and Anti-apelin Antibodies in Serum
Pharmacokinetic of CLR325 and CQJ295: Amount of Drug (or Defined Metabolite) Excreted Into the Urine From Time (Ae 0-28 Hours)
Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From From Time Zero to 28 Hours (AUC0-28hrs)
+9 moreSide effects data
From 2019 Phase 2 trial • 26 Patients • NCT0269696725%
Nausea
25%
Infusion site pruritus
25%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
CLR325 0.25 mcg/kg/Min
CLR325 2.5 mcg/kg/Min
CLR325 8 mcg/kg/Min
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CLR325Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CLR325
2016
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,859 Total Patients Enrolled