Raised Intraocular PressurePhase 2NCT01173471

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

A Phase 2 study testing AZD4017 in people with Raised Intraocular Pressure, run by AstraZeneca at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Raised Intraocular Pressure
What is being tested?: AZD4017
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 11 sitesin 3 countries
Study dates: Dec 2010to Nov 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

11 sites in 3 countries.

Country

City, postcode or hospital

11 sites in 3 countries

United States7 sites

Research Site
Atlanta, Georgia
Research Site
Charlotte, North Carolina
Research Site
Durham, North Carolina
Research Site
Memphis, Tennessee
Research Site
Morrow, Georgia
Research Site
Newport Beach, California
Research Site
Overland Park, Kansas

Other trials in United States

Sweden3 sites

Research Site
Lund
Research Site
Mölndal
Research Site
Stockholm

Other trials in Sweden

United Kingdom1 site

Research Site
Nottingham

Other trials in United Kingdom

About this study

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

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).

Conditions: Raised Intraocular Pressure
Being tested: AZD4017, Placebo
Keywords: Raised intraocular pressure
Medical subject headings: Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD4017Drug
tablet, oral, one tablet once daily, 28 days
PlaceboDrug
matching placebo tablet, oral, one tablet once daily, 28 days
AZD4017Drug
tablet, oral 2 tablets twice daily, 28 days
PlaceboDrug
matching placebo tablets, oral, 2 tablets twice daily, 28 days

Study groups in NCT01173471
Study group	Role	What they receive
1) AZD4017	Experimental	Europe: 200 mg AZD4017 Receives: Drug: AZD4017
2) Placebo	Placebo comparator	Europe: placebo Receives: Drug: Placebo
3) AZD4017	Experimental	USA: 800 mg AZD4017 Receives: Drug: AZD4017
4) Placebo	Placebo comparator	USA: placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
Measured: Baseline to 4 weeks

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Nov 2012

First posted2 Aug 2010 (estimated)
Study startDec 2010
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Raised Intraocular PressureStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01173471
Sponsor's protocol ID: D4250C00001
Other IDs: 2010-020932-20
Status last verified: Jan 2014
First submitted: 29 Jul 2010
Last updated: 14 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Raised Intraocular Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01173471
Acronym / sponsor ID: D4250C00001
Conditions: Raised Intraocular Pressure
Keywords: Raised intraocular pressure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 2 Aug 2010 (estimated)
Results: Posted 14 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1) AZD4017	Experimental	Drug: AZD4017Europe: 200 mg AZD4017
2) Placebo	Placebo comparator	Drug: PlaceboEurope: placebo
3) AZD4017	Experimental	Drug: AZD4017USA: 800 mg AZD4017
4) Placebo	Placebo comparator	Drug: PlaceboUSA: placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD4017tablet, oral, one tablet once daily, 28 days	Drug	1) AZD4017
Placebomatching placebo tablet, oral, one tablet once daily, 28 days	Drug	2) Placebo
AZD4017tablet, oral 2 tablets twice daily, 28 days	Drug	3) AZD4017
Placebomatching placebo tablets, oral, 2 tablets twice daily, 28 days	Drug	4) Placebo

Primary outcome

Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
Time frame: Baseline to 4 weeks

2 secondary outcomes

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

Results and safety

Results posted to the registry on 14 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo OD	6	4
AZD4017 200 mg OD	7	7
Placebo BID	18	15
AZD4017 400 mg BID	19	18

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

Time frame: Baseline to 4 weeks. Least squares mean (95% Confidence Interval). Unit: Percentage change

Measure	Placebo OD n = 6	AZD4017 200 mg OD n = 7	Placebo BID n = 16	AZD4017 400 mg BID n = 19
Value	0.8 (-15.6 to 17.3)	-0.4 (-13.8 to 13.0)	-8.1 (-13.3 to -2.9)	-11.0 (-15.8 to -6.2)

Placebo OD vs AZD4017 200 mg OD: Mean Difference (Final Values): -1.3 (95% CI -15.2 to 12.6), p = 0.822, Mixed Models Analysis
Placebo BID vs AZD4017 400 mg BID: Mean Difference (Final Values): -2.9 (95% CI -10.1 to 4.3), p = 0.413, Mixed Models Analysis

Population analysed: Efficacy analysis set

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4-week treatment period.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo OD	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
AZD4017 200 mg OD	0 of 7 (0%)	3 of 7 (42.9%)	Not reported
Placebo BID	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
AZD4017 400 mg BID	0 of 19 (0%)	7 of 19 (36.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heather Bryson, PhD study director

AstraZeneca R&D

Tony Ho, MD study director

AstraZeneca R&D

11 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD4017 in people with Raised Intraocular Pressure, run by AstraZeneca at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01173471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.