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

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

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).

Study Overview

• Status: Completed
• Conditions: Raised Intraocular Pressure
• Intervention / Treatment: Drug: AZD4017; Drug: AZD4017; Drug: Placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1) AZD4017; Europe: 200 mg AZD4017	Drug: AZD4017; tablet, oral, one tablet once daily, 28 days; Drug: AZD4017; tablet, oral 2 tablets twice daily, 28 days
Placebo Comparator: 2) Placebo; Europe: placebo	Drug: Placebo; matching placebo tablet, oral, one tablet once daily, 28 days; Drug: Placebo; matching placebo tablets, oral, 2 tablets twice daily, 28 days
Experimental: 3) AZD4017; USA: 800 mg AZD4017	Drug: AZD4017; tablet, oral, one tablet once daily, 28 days; Drug: AZD4017; tablet, oral 2 tablets twice daily, 28 days
Placebo Comparator: 4) Placebo; USA: placebo	Drug: Placebo; matching placebo tablet, oral, one tablet once daily, 28 days; Drug: Placebo; matching placebo tablets, oral, 2 tablets twice daily, 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment	Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment	Baseline to 4 weeks
Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment	Baseline to 4 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Heather Bryson, PhD, AstraZeneca R&D; Study Director: Tony Ho, MD, AstraZeneca R&D

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: July 29, 2010
• First Posted (Estimate): August 2, 2010

Study Record Updates

• Last Update Posted (Estimate): February 14, 2014
• Last Update Submitted That Met QC Criteria: January 20, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Raised intraocular pressure
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Niacinamide
• Other Study ID Numbers: D4250C00001; 2010-020932-20 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No