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OpenTrials
Completed

NCT Number: NCT00503360

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

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

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Key information

Conditions

Ocular Hypertension Eye Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative site, Sydney, Australia

Sydney, Australia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAD448

Drug

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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
First posted
Jul 18, 2007
Registry last updated
Apr 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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