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CompletedNCT00503360Updated Apr 24, 2008

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

A Phase 1 interventional study of SAD448 in Ocular Hypertension, sponsored by Novartis. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-04-24.

Sponsored by Novartis · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ocular Hypertension

Keywords

  • Ocular Hypertension
  • SAD448
03

In context

Ocular Hypertension

649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.

This study's planned enrollment of 80 is below the median of 120 across 510 interventional studies indexed under Ocular Hypertension.

Browse Ocular Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
80 participants (estimated)

Interventions

  • DrugSAD448
06

What researchers measure

Primary outcomes

  1. 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 outcomes

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

07

Study locations

1 site
  • Novartis Investigative site, Sydney, Australia
    Sydney, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00503360
Lead sponsor
Novartis
First posted
Jul 18, 2007
Start date
Apr 2007
Last update
Apr 24, 2008

Study contacts

Novartis
study director · Novartis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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