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

Primary Purpose

Raised Intraocular Pressure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD4017
Placebo
AZD4017
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Raised Intraocular Pressure focused on measuring Raised intraocular pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

1) AZD4017

2) Placebo

3) AZD4017

4) Placebo

Arm Description

Europe: 200 mg AZD4017

Europe: placebo

USA: 800 mg AZD4017

USA: placebo

Outcomes

Primary Outcome Measures

Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment

Secondary Outcome Measures

Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment
Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment

Full Information

First Posted
July 29, 2010
Last Updated
January 20, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01173471
Brief Title
A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raised Intraocular Pressure
Keywords
Raised intraocular pressure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1) AZD4017
Arm Type
Experimental
Arm Description
Europe: 200 mg AZD4017
Arm Title
2) Placebo
Arm Type
Placebo Comparator
Arm Description
Europe: placebo
Arm Title
3) AZD4017
Arm Type
Experimental
Arm Description
USA: 800 mg AZD4017
Arm Title
4) Placebo
Arm Type
Placebo Comparator
Arm Description
USA: placebo
Intervention Type
Drug
Intervention Name(s)
AZD4017
Intervention Description
tablet, oral, one tablet once daily, 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo tablet, oral, one tablet once daily, 28 days
Intervention Type
Drug
Intervention Name(s)
AZD4017
Intervention Description
tablet, oral 2 tablets twice daily, 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo tablets, oral, 2 tablets twice daily, 28 days
Primary Outcome Measure Information:
Title
Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
Time Frame
Baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment
Time Frame
Baseline to 4 weeks
Title
Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
Time Frame
Baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Bryson, PhD
Organizational Affiliation
AstraZeneca R&D
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tony Ho, MD
Organizational Affiliation
AstraZeneca R&D
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Morrow
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Molndal
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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