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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00503360
First received: July 17, 2007
Last updated: April 23, 2008
Last verified: April 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503360

Locations
Australia
Novartis Investigative site, Sydney, Australia
Sydney, Australia
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

ClinicalTrials.gov 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
SAD448

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013