Clinical Trials Register

Summary
EudraCT Number:	2019-000919-85
Sponsor's Protocol Code Number:	DP13C201
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-02-04
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

Netherlands - Competent Authority

A.2

EudraCT number

2019-000919-85

A.3

Full title of the trial

DP13 – A Phase II Study in Patients with Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of the Aldosterone Synthase Inhibitor, DP13, over an 8-week Treatment Period

A.3.1

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

Study in Patients with Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of the Aldosterone Synthase Inhibitor, DP13, over an 8-week Treatment Period

A.4.1

Sponsor's protocol code number

DP13C201

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	DAMIAN Pharma AG
B.1.3.4	Country	Switzerland
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	DAMIAN Pharma AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	DAMIAN Pharma AG
B.5.2	Functional name of contact point	Christoph Schumacher
B.5.3	Address:
B.5.3.1	Street Address	Haltli 6
B.5.3.2	Town/ city	Walchwil
B.5.3.3	Post code	6318
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41415004232
B.5.5	Fax number	+41417606667
B.5.6	E-mail	christoph.schumacher@damianpharma.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	DP13
D.3.2	Product code	DP13
D.3.4	Pharmaceutical form	Capsule
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.3.8	INN - Proposed INN	FADROZOLE
D.3.9.1	CAS number	102676-47-1
D.3.9.2	Current sponsor code	DP13
D.3.9.3	Other descriptive name	5R-(+)-Fadrozole-Enantiomer Phosphate
D.3.9.4	EV Substance Code	SUB07497MIG
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	4
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.IMP: 2
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	DP13
D.3.2	Product code	DP13
D.3.4	Pharmaceutical form	Capsule
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.3.8	INN - Proposed INN	FADROZOLE
D.3.9.1	CAS number	102676-47-1
D.3.9.2	Current sponsor code	DP13
D.3.9.3	Other descriptive name	5R-(+)-Fadrozole-Enantiomer Phosphate
D.3.9.4	EV Substance Code	SUB07497MIG
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	8
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.IMP: 3
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	DP13
D.3.2	Product code	DP13
D.3.4	Pharmaceutical form	Capsule
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.3.8	INN - Proposed INN	FADROZOLE
D.3.9.1	CAS number	102676-47-1
D.3.9.2	Current sponsor code	DP13
D.3.9.3	Other descriptive name	5R-(+)-Fadrozole-Enantiomer Phosphate
D.3.9.4	EV Substance Code	SUB07497MIG
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	12
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	Capsule
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

Primary Aldosteronism

E.1.1.1

Medical condition in easily understood language

Primary Aldosteronism

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10001656
E.1.2	Term	Aldosteronism
E.1.2	System Organ Class	100000004860

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

• To determine the efficacy of daily oral DP13 treatment (all dose arms combined) to decrease the plasma aldosterone-to-renin ratio (ARR) from baseline in patients with primary aldosteronism (PA)
• To determine the efficacy of daily oral DP13 treatment (all dose arms combined) to reduce 24-hour ambulatory systolic blood pressure (aSBP) from baseline in patients
with PA

E.2.2

Secondary objectives of the trial

• To determine the safety and tolerability of DP13 treatment in patients with PA
• To determine the efficacy of daily oral DP13 treatment (all dose arms combined) to reduce office systolic blood pressure (oSBP) from baseline in patients with PA
• To determine the efficacy of daily oral DP13 treatment to decrease the plasma ARR from baseline in each individual dose arm
• To determine the efficacy of daily oral DP13 treatment to reduce 24-hour aSBP from baseline in each individual dose arm
• To determine the efficacy of daily oral DP13 treatment to reduce oSBP from baseline in each individual dose arm
• To determine the dose-dependent efficacy of daily oral DP13 treatment to decrease the ARR from baseline in patients with PA
• To determine the dose-dependent efficacy of daily oral DP13 treatment to reduce 24- hour aSBP from baseline in patients with PA
• To determine the dose-dependent efficacy of daily oral DP13 treatment to reduce oSBP from baseline in patients with PA

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-1. Patients with a guideline-recommended diagnosis of PA consisting of:
1.1. ARR ≥40 derived from a PAC ≥15 ng/dL and a PRA <1.0 ng/mL/h; an ARR ≥3.7 is derived with PRC <15 mU/L instead of PRA as denominator and
1.2. PAC >7.0 ng/dL after a 4-hour infusion of 2 litres 0.9% saline (saline load suppression test) or instead if clinically justified for risk of volume expansion ARR>30 and PAC >11 ng/dL (respectively ARR>2.4 with PRC in mU/L instead of PRA as denominator) after 2 hours of an oral intake of 50 mg captopril and
1.3. determined within <1 year of study enrolment
-2. Patients with PA per above criteria and
2.1. sitting office systolic blood pressure (oSBP) >145 mmHg
and if applicable
2.2. in presence of non-interfering hypertension control therapy consisting of doxazosin (1 – 8 mg QD) as first-line medication and, if necessary, only verapamil slow release (40 – 120 mg BID) or diltiazem (slow-release 90 - 360 mg daily) or amlodipine (2.5 – 10 mg QD) at adjusted and fixed doses
- 3. Patients with PA per above criteria will have a:
3.1. estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 using the MDRD-4
GFR equation: GFR = 1.75 x [serum creatinine (mg/dL)]-1.154 x (age)-0.203 x f*
*f=1.000 for men; f=0.742 for women; the formula is further multiplied by factor 1.210 for
black skinned patients
3.2. body mass index (BMI) between 18 and 34 kg/m2, inclusive
3.3. body weight between 40 and 110 kg, inclusive
- 4. Patients with PA per above criteria will be:
4.1. female or male patients between 18 and 65 years of age, inclusive
4.2. able to provide voluntary informed written consent to study enrolment

E.4

Principal exclusion criteria

-1. Patients with PA and:
1.1. treated with spironolactone within 2 months of enrolment
1.2. hyperkalaemia of >5.0 mmol/L
1.3. prolonged QT intervals with QTc of >500 msec using Bazett’s formula
-2. Patients with PA and:
2.1. sitting office systolic office blood pressure (oSBP) >190 mmHg
and/or
2.2. sitting office diastolic office blood pressure (oDBP) >110 mmHg
and if applicable
2.3. in presence of non-interfering hypertension control therapy consisting of doxazosin (1– 8 mg QD) as first-line medication and, if necessary, only verapamil slow release (40– 120 mg BID) or diltiazem (slow-release 90 - 360 mg daily) or amlodipine (2.5 – 10 mg QD) at adjusted and fixed doses
-3. Patients with PA who will not consent to special contraception measures during the entire
study period, specifically
3.1. female patients not withdrawing oral contraceptives >2 weeks prior to enrolment
3.2. female patients not using intrauterine devices (IUD), diaphragm, or sponge with spermicide
3.3. male patients not using condoms and not refraining from sperm donation
-4. Patients with PA and a medical history of:
4.1. cerebro- and cardiovascular events (stroke, myocardial infarction, percutaneous transluminal coronary angioplasty, long QT syndrome, Brugada syndrome, acute heart failure) within 6 months of study enrolment
4.2. gastrointestinal tract surgeries or malabsorption syndromes
4.3. chronic use of oral or parenteral corticosteroids
4.4. use of drugs prolonging the QT interval (e.g., digoxin, sotalol)
-5. Patients with PA who:
5.1. participated in any clinical study within 6 weeks
5.2. suffered a significant blood loss within <2 months
5.3. had a significant illness within <2 weeks
5.4. are pregnant or breastfeeding
5.5. are unable to follow all study procedures

E.5 End points

E.5.1

Primary end point(s)

• Change in the plasma ARR for all dose arms combined
• Change in mean 24-hour aSBP for all dose arms combined

E.5.1.1

Timepoint(s) of evaluation of this end point

• from baseline (Day 1) to the end of the 8-week daily oral DP13 treatment period (Day 56)
• from baseline (Day 1) to the end of the 8-week daily oral DP13 treatment period (Day 56)

E.5.2

Secondary end point(s)

• Occurrence of treatment-emergent adverse events (TEAE) and serious adverse events (SAE)
• Change in oSBP for all dose arms combined
• Change in the plasma ARR in each individual dose arm
• Change in 24-hour aSBP in each individual dose arm
• Change in oSBP from baseline in each individual dose arm

E.5.2.1

Timepoint(s) of evaluation of this end point

• over the entire study duration
• from baseline (Day 1) to the end of the 8-week daily oral DP13 treatment period (Day 56)
• from baseline (Day 1) to biweekly visits (week 2, week 4, week 6) and to the end of the 8-week daily oral DP13 treatment period (Day 56)
• from baseline (Day 1) to biweekly visits (week 2, week 4, week 6) and to the end of the 8-week daily oral DP13 treatment period (Day 56)
• from baseline (Day 1) to biweekly visits (week 2, week 4, week 6) and to the end of the 8-week daily oral DP13 treatment period (Day 56)

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

different dosage of the same product

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.8.5

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

Switzerland

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

LVLS

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

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Standard of care

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

2020-02-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-14

P. End of Trial
P.	End of Trial Status	Ongoing

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