A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure

Raised Intraocular Pressure Clinical Trial

Official title:

A Double Masked, Placebo Controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-Ocular Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173471
• Other study ID #: D4250C00001
• Secondary ID: 2010-020932-20
• Status: Completed
• Phase: Phase 2
• First received: July 29, 2010
• Last updated: January 20, 2014
• Start date: December 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Must have a diagnosis of intra-ocular hypertension (raised IOP), or primary open-angle glaucoma (POAG), with IOP >20 mmHg and =36 mmHg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the screening visit; OR

• Must have a diagnosis of intra-ocular hypertension (raised IOP), defined as an IOP =22 mmHg and =36 mmHg in the study eye while not on anti-glaucoma medication

• Male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with IP

• Placebo treatment for duration of the study must not be considered detrimental to the patient

Exclusion Criteria:

• Have uncontrolled intra-ocular hypertension (>36 mmHg)

• Have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by >1 dB/yr average loss or vision threatening new defect)

• Have had severe eye trauma at any time

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glaucoma
• Raised Intraocular Pressure

Intervention

Drug:
• AZD4017
tablet, oral, one tablet once daily, 28 days
• Placebo
matching placebo tablet, oral, one tablet once daily, 28 days
• AZD4017
tablet, oral 2 tablets twice daily, 28 days
• Placebo
matching placebo tablets, oral, 2 tablets twice daily, 28 days

Locations

Country	Name	City	State
Sweden	Research Site	Lund
Sweden	Research Site	Molndal
Sweden	Research Site	Stockholm
United Kingdom	Research Site	Nottingham
United States	Research Site	Atlanta	Georgia
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Durham	North Carolina
United States	Research Site	Memphis	Tennessee
United States	Research Site	Morrow	Georgia
United States	Research Site	Newport Beach	California
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment		Baseline to 4 weeks	No
Secondary	Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment		Baseline to 4 weeks	No
Secondary	Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment		Baseline to 4 weeks	No