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

April 23, 2008 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia
        • Novartis Investigative site, Sydney, Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (ESTIMATE)

July 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2008

Last Update Submitted That Met QC Criteria

April 23, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSAD448B2101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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