Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT00709904
Brief Summary:
The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery.
The secondary objective is to evaluate the safety of extended AVE5026 administration.
Detailed Description:
The total duration of observation per participant is 56-63 days from surgery broken down as follows:
* 7 to 10-day initial treatment period with open-label Semuloparin sodium;
* Randomization;
* 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo;
* 30-day follow-up period.
Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.
Study:
NCT00709904
Study Brief:
Protocol Section:
NCT00709904