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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503360
• Other study ID #: CSAD448B2101
• Status: Completed
• Phase: Phase 1
• First received: July 17, 2007
• Last updated: April 23, 2008
• Start date: April 2007

Study information

• Verified date: April 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Key inclusion criteria:

• Males and females, 18 - 65 years of age, with ocular hypertension

• Females must be post-menopausal or surgically sterile

Key exclusion criteria:

• Diagnosis of glaucoma in either eye

• A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Ocular Hypertension

Intervention

Drug:
• SAD448

Locations

Country	Name	City	State
Australia	Novartis Investigative site, Sydney, Australia	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.