Autopsy report · NCT00343395

Rosiglitazone and Metformin: Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes (Romance) Pilot Study

“FDA concerns regarding Avandamet”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 1 year 7 months before it stopped.
• 200 participants planned (an estimate, not an actual count).
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

Intermountain Health Care, Inc.

Sponsor type

University, hospital or other

Conditions

Coronary Artery Disease

Interventions

AVANDAMET

Participants

200 (planned, not actual)

Sites

1

Countries

United States

Trials that died the same way

• MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly
  “FDA hold on the project” (57% match in meaning)
• Electrical Impedence Tomography With ENLIGHT2100
  “Device received FDA approval” (57% 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.