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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: July 17, 2007
Last updated: April 23, 2008
Last verified: April 2008
This study will evaluate the tolerability and safety of SAD448 and explore the compound's effect on intraocular pressure in subjects with ocular hypertension.

Condition Intervention Phase
Ocular Hypertension
Drug: SAD448
Phase 1

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

Resource links provided by NLM:

Further study details as provided by Novartis:

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.

Estimated Enrollment: 80
Study Start Date: April 2007

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00503360

Novartis Investigative site, Sydney, Australia
Sydney, Australia
Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information Identifier: NCT00503360     History of Changes
Other Study ID Numbers: CSAD448B2101 
Study First Received: July 17, 2007
Last Updated: April 23, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
Ocular Hypertension

Additional relevant MeSH terms:
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases processed this record on May 04, 2016