Back to resultsTolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension
Primary Purpose
Ocular Hypertension
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
SAD448
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension focused on measuring Ocular Hypertension, SAD448
Eligibility Criteria
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
Sites / Locations
- Novartis Investigative site, Sydney, Australia
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00503360
Brief Title
Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension
Keywords
Ocular Hypertension, SAD448
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SAD448
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative site, Sydney, Australia
City
Sydney
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension
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