AZD4017 for Raised Intra-Ocular Pressure

• Research type

  Research Study

• Full title

  A Double Masked, Placebo Controlled, Randomised, Parallel Group Phase IIa Study to assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-Ocular Pressure

• IRAS ID

  56904

• Contact name

  Jonathan Clarke

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2010-020932-20

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study is being carried out to see if AZD4017 administered for 28 days is effective in treating raised intra-ocular Pressure and if so, how it comparts with placebo. The study will measure levels of medication in the blood and see how well it is tolerated. It will be run in 2 cohorts. In the first cohort patients will receive either low dose (200 mg) AZD4017 or placebo, and in the second cohort patients will receive a higher dose of AZD4017 (between 400 mg and 1200 mg, inclusive) or placebo. The need for the second cohort and the selection of the higher dose will be determined following a review of the primary efficacy endpoint data and the safety data from the first cohort. The study consists of a pre-screening visit (Visit 1), a screening visit (Visit 2), a baseline (randomization) visit (Visit 3), and 4 further weekly visits during a treatment period of 28 days. patients who complete the 4-week treatment period and assessments will be defined as having completed the study for the purposes of the data analysis. However, all patients will be required to return for a mandatory follow-up visit between 14 days and 21 days, inclusive, after the last dose of study medication. Any ongoing Adverse events (AEs) at the follow-up visit must be followed until resolution, until the AE stabilises, until it is otherwise explained, or until the patient is lost to follow-up.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/57

• Date of REC Opinion

  5 Oct 2010

• REC opinion

  Further Information Favourable Opinion