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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00503360




Registration number
NCT00503360
Ethics application status
Date submitted
17/07/2007
Date registered
18/07/2007
Date last updated
24/04/2008

Titles & IDs
Public title
Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension
Scientific 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
Secondary ID [1] 0 0
CSAD448B2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.
Timepoint [1] 0 0

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative site, Sydney, Australia - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00503360
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis
Address 0 0
Novartis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00503360