Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension

Phase 1

Completed

• Conditions: Ocular Hypertension

• Registration Number: NCT00503360
• Lead Sponsor: Novartis

Brief Summary

This study will evaluate the tolerability and safety of SAD448 and explore the compound's effect on intraocular pressure in subjects with ocular hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-23
• Last Update Posted: 2008-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.

Trial Locations

Locations (1)

Novartis Investigative site, Sydney, Australia; 🇦🇺 Sydney, Australia