Autopsy report · NCT01332331

Efficacy and Safety of Ambrisentan in Children 8-18yrs

“Ongoing juvenile rat toxicology studies.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 months after it had already started.
• Ran for about 2 years 10 months before it stopped.
• 41 participants enrolled.
• Results were posted on the registry 5 years 11 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

GlaxoSmithKline

Sponsor type

Industry

Conditions

Hypertension, Pulmonary

Interventions

Ambrisentan - low dose; Ambrisentan - high dose

Participants

41

Sites

24

Countries

Argentina, France, Germany, Hungary, Italy, Japan, Russia, Spain, United States

Trials that died the same way

• Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants
  “Long-term animal toxicology findings (see detailed description).” (65% match in meaning)
• A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population
  “The study was stoppend before recruitment start for preclinical safety finding in rats.” (55% 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.