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

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ClinicalTrials.gov Identifier: NCT00503360
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : April 24, 2008
Sponsor:
Information provided by:
Novartis

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.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Drug: SAD448 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2007



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


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503360


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

ClinicalTrials.gov Identifier: NCT00503360     History of Changes
Other Study ID Numbers: CSAD448B2101
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: April 24, 2008
Last Verified: April 2008

Keywords provided by Novartis:
Ocular Hypertension
SAD448

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