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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01173471
First received: July 29, 2010
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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).     


Condition Intervention Phase
Raised Intraocular Pressure
Drug: AZD4017
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
  • Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1) AZD4017
Europe: 200 mg AZD4017
Drug: AZD4017
tablet, oral, one tablet once daily, 28 days
Placebo Comparator: 2) Placebo
Europe: placebo
Drug: Placebo
matching placebo tablet, oral, one tablet once daily, 28 days
Experimental: 3) AZD4017
USA: 800 mg AZD4017
Drug: AZD4017
tablet, oral 2 tablets twice daily, 28 days
Placebo Comparator: 4) Placebo
USA: placebo
Drug: Placebo
matching placebo tablets, oral, 2 tablets twice daily, 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173471

Locations
United States, California
Research Site
Newport Beach, California, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
Research Site
Morrow, Georgia, United States
United States, Kansas
Research Site
Overland Park, Kansas, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
Sweden
Research Site
Lund, Sweden
Research Site
Molndal, Sweden
Research Site
Stockholm, Sweden
United Kingdom
Research Site
Nottingham, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Heather Bryson, PhD AstraZeneca R&D
Study Director: Tony Ho, MD AstraZeneca R&D
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01173471     History of Changes
Other Study ID Numbers: D4250C00001, 2010-020932-20
Study First Received: July 29, 2010
Results First Received: August 2, 2013
Last Updated: January 20, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Raised intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014