Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension
This study has been completed.
Information provided by:
First received: July 17, 2007
Last updated: April 23, 2008
Last verified: April 2008
This study will evaluate the tolerability and safety of SAD448 and explore the compound's effect on intraocular pressure in subjects with ocular hypertension.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Placebo-Controlled, Double-Masked, 4-Arm Parallel Group Study to Assess the Tolerability, Safety and Efficacy of Two Doses of SAD448 in Subjects With Ocular Hypertension|
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs from baseline up to 24 hours post-dosing.
Secondary Outcome Measures:
- Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.
|Study Start Date:||April 2007|
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