Autopsy report · NCT01035255

This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

“Early termination was approved due to compelling efficacy of LCZ696 in patients with HF \& reduced EF after final pre-specified interim analysis 28-Mar-2014.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 4 years 5 months before it stopped.
• 8,442 participants enrolled.
• Results were posted on the registry 1 year 4 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Heart Failure With Reduced Ejection Fraction

Interventions

LCZ696 200 mg BID; Enalapril 10 mg BID

Participants

8,442

Sites

1,031

Countries

Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Dominican Republic, Ecuador and more

Trials that died the same way

• Topical rVA576 for Treatment of Atopic Keratoconjunctivitis
  “The trial has terminated early due to the disruptions caused by the ongoing COVID-19 pandemic. The decision was not related to any efficacy, safety or clinical concerns regarding rVA576.” (58% match in meaning)
• Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
  “The early termination is due to the results obtained from the sister study, SAPPHIRE (CLS1003-301), which did not meet the 8-week primary efficacy endpoint.” (58% match in meaning)
• A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
  “The study was terminated due to regulatory approval of newer therapeutic options and slower than anticipated accrual.” (57% match in meaning)
• Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer
  “The study was terminated on the basis on an evaluation of the safety and efficacy of the 9 included patients of which 2 of the patients were excluded before receiving any study treatments, thus 7 patients were treated in the study.” (57% match in meaning)
• Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
  “The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522)” (56% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.