Clinical Trials Register

Summary
EudraCT Number:	2010-020932-20
Sponsor's Protocol Code Number:	D4250C00001
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-06-30
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2010-020932-20

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A placebo controlled trial investigating the safety and effectiveness of AZD4017 in patients with raised intra-ocular pressure

A.4.1

Sponsor's protocol code number

D4250C00001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AstraZeneca AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Astra Zeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	Forskargatan 18
B.5.3.2	Town/ city	Södertälje
B.5.3.3	Post code	SE-151 85
B.5.3.4	Country	Sweden
B.5.6	E-mail	information.center@astrazeneca.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	AZD4017
D.3.2	Product code	AZD4017
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1024033-43-9
D.3.9.2	Current sponsor code	AZD4017
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Raised Intra-Ocular Pressure or primary
open angle glaucoma (POAG) on anti-glaucoma monotherapy that has been stable in
dose for at least 30 days prior to screening.

E.1.1.1

Medical condition in easily understood language

Raised pressure within the eye or glaucoma

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10036719
E.1.2	Term	Primary open angle glaucoma
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10022809
E.1.2	Term	Intraocular pressure raised
E.1.2	System Organ Class	10022891 - Investigations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective 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) not on anti-glaucoma medication or patients with raised IOP or primary open angle glaucoma (POAG) on anti-glaucoma monotherapy that has been stable in dose for at least 30 days prior to screening. The primary efficacy variable will be the percentage decrease in IOP compared with baseline after 28 days of treatment.

E.2.2

Secondary objectives of the trial

• To compare the safety and tolerability of systemically administered AZD4017 with placebo, by evaluation of safety variables.
• To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of AZD4017

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provision of informed consent prior to any study specific procedures.
2. Non-diabetic males and females aged 18 to 80 years, inclusive.
3. 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.
4. Must have a best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.6 logarithm of the minimum angle of resolution (logMAR [Snellen equivalent of 20/80]) or better in each eye.
5. Must have a <5 mmHg difference in mean IOP between eyes at 9AM at Baseline (Visit 3).
6. 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.
7. Placebo treatment for duration of the study must not be considered detrimental to the patient.
8. Must be willing to discontinue soft contact lens wear from 7 days prior to Visit 3 until the completion of the final study visit or to discontinue hard contact lens wear from 1 month prior to Visit 3 until the completion of the final study visit.
9. Must be able to understand the consent form and comply with study requirements.

E.4

Principal exclusion criteria

Ocular 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). Patients with severe central field loss in either eye is defined as a sensitivity ≤10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
- Have narrow anterior chamber angles in either eye judged potentially occludable if pupillary dilatation were to occur, evidence or history of acute or chronic angle closure, or is at risk for angle closure as evidenced by anterior chamber angle less than grade 2 according to Schaffer classification, as measured by gonioscopy

General Exclusion Criteria:
- Women of child-bearing potential (WOCBP).
- Have uncontrolled systemic hypertension (BP >150/90)
- Are receiving systemic (including vaginal/rectal) or inhaled steroid treatment at the time of the screening visit (Visit 2).
- Have any screening laboratory abnormality that, in the investigator’s judgement, is considered to be clinically significant.
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject’s ability to participate in the study.
- Had a change in dose or initiation of systemic therapies (including herbal medications, vitamins, and nutrient supplements [eg, fish oil, and zinc]) that can substantially affect IOP or the study outcome, such as (but not limited to) alpha adrenergic agents, beta-adrenergic blockers, calcium channel blockers, carbonic anhydrase inhibitors, angiotensin-converting enzyme inhibitors or other antihypertensive medications within 30 days prior to the screening visit (Visit 2), or anticipates a change in such therapy during the study.

E.5 End points

E.5.1

Primary end point(s)

Percentage decrease from baseline in IOP at endpoint

E.5.1.1

Timepoint(s) of evaluation of this end point

Final visit assessment

E.5.2

Secondary end point(s)

1 - Number of patients experiencing a clinically relevant decrease in IOP
2 − Change from baseline to final visit in eye exams, IOP measurements, corneal thickness, clinical laboratory test results, and vital signs
3 − Incidence of AEs, DAEs, SAEs

E.5.2.1

Timepoint(s) of evaluation of this end point

1 - Day 28
2 - Throughout study participation
3 - Throughout study participation

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Sweden

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of the study is defined as ‘the last visit of the last patient undergoing the study’

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	12
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	48
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	20
F.4.2	For a multinational trial
F.4.2.1	In the EEA	30
F.4.2.2	In the whole clinical trial	60

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-08-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-10-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-11-30

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