NCT01173471

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2010

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 14, 2013

Completed
Last Updated

February 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1.9 years

First QC Date

July 29, 2010

Results QC Date

August 2, 2013

Last Update Submit

January 20, 2014

Conditions

Raised Intraocular Pressure

Keywords

Raised intraocular pressure

Outcome Measures

Primary Outcomes (1)

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

    Baseline to 4 weeks

Secondary Outcomes (2)

  • 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

Study Arms (4)

1) AZD4017

EXPERIMENTAL

Europe: 200 mg AZD4017

Drug: AZD4017

2) Placebo

PLACEBO COMPARATOR

Europe: placebo

Drug: Placebo

3) AZD4017

EXPERIMENTAL

USA: 800 mg AZD4017

Drug: AZD4017

4) Placebo

PLACEBO COMPARATOR

USA: placebo

Drug: Placebo

Interventions

AZD4017DRUG

tablet, oral, one tablet once daily, 28 days

1) AZD4017
PlaceboDRUG

matching placebo tablet, oral, one tablet once daily, 28 days

2) Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Newport Beach, California, United States

Location

Research Site

Atlanta, Georgia, United States

Location

Research Site

Morrow, Georgia, United States

Location

Research Site

Overland Park, Kansas, United States

Location

Research Site

Charlotte, North Carolina, United States

Location

Research Site

Durham, North Carolina, United States

Location

Research Site

Memphis, Tennessee, United States

Location

Research Site

Lund, Sweden

Location

Research Site

Mölndal, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Ocular Hypertension

Interventions

2-(1-(5-(cyclohexylcarbamoyl)-6-propylsulfanylpyridin-2-yl)-3-piperidyl)acetic acid

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Stuart McIntosh
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Heather Bryson, PhD

    AstraZeneca R&D

    STUDY DIRECTOR

  • Tony Ho, MD

    AstraZeneca R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2010

First Posted

August 2, 2010

Study Start

December 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 14, 2014

Results First Posted

October 14, 2013

Record last verified: 2014-01

Locations

SE(3)US(7)GB(1)