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

NCT ID: NCT00503360

Last Updated: 2008-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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

Detailed Description

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Conditions

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Ocular Hypertension

Keywords

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Ocular Hypertension SAD448

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SAD448

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females, 18 - 65 years of age, with ocular hypertension
* Females must be post-menopausal or surgically sterile

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis Investigative site, Sydney, Australia

Sydney, , Australia

Site Status

Countries

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Australia

Other Identifiers

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CSAD448B2101

Identifier Type: -

Identifier Source: org_study_id