PROspective PioglitAzone Clinical Trial in MacroVascular Events (PROactive)

Study identification

• EU PAS number:
  EUPAS10493
• Study ID:
  10494
• Official title and acronym:
  PROspective PioglitAzone Clinical Trial in MacroVascular Events (PROactive)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  Estonia

  Finland

  France

  Germany

  Hungary

  Italy

  Latvia

  Lithuania

  Netherlands

  Norway

  Poland

  Slovakia

  Sweden

  Switzerland

  United Kingdom
• Study description:
  The risk reduction by pioglitazone in cardiovascular (CV) outcomes in high risk patients with Type 2 diabetes mellitus (T2DM) and pre-existing macrovascular disease was evaluated during the PROactive study. It was a multicenter, randomized, double-blind, placebo-controlled, parallel group study conducted in male and female patients between 35 and 75 years with a diagnosis of T2DM. Patients received 15 milligram (mg) dose of pioglitazone (or matching placebo), once daily along with the current diabetic medications. Doses were titrated from 15 mg to 30 mg in the first month visit, 30 mg to 45 mg in the second month visit and was maintained at 45 mg for a period of 2.5 to 3.5 years, unless there were any tolerability concerns. Visits were scheduled at 1,2,4,6,8,10 and 12 months following randomization and then every 3 months thereafter. Patients continued study medication until 30 months follow-up was reached or a study total of 760 macrovascular events had been reported, and final visits were completed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 321 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:28/05/2001

Study start date

Actual:28/05/2001

Date of final study report

Actual:29/11/2005

Sources of funding

Other

More details on funding

Takeda Europe R&D Centre Ltd

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable