A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01173471
First received: July 29, 2010
Last updated: December 19, 2012
Last verified: December 2012
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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:
- The percentage decrease in IOP compared with baseline after 28 days of treatment [ Time Frame: Each clinic visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of patients experiencing a clinically relevant decrease, ie, at least 20% reduction, in IOP [ Time Frame: at visit 7 ] [ Designated as safety issue: No ]
- Change from baseline to final visit in IOP measurements [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: Yes ]
| 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
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 |
| Last Updated: | December 19, 2012 |
| 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 May 22, 2013