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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03541174




Registration number
NCT03541174
Ethics application status
Date submitted
17/05/2018
Date registered
29/05/2018
Date last updated
19/12/2018

Titles & IDs
Public title
A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety
Scientific title
Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)
Secondary ID [1] 0 0
2017-004393-33
Secondary ID [2] 0 0
ID-080A301
Universal Trial Number (UTN)
Trial acronym
PRECISION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aprocitentan 12.5 mg
Treatment: Drugs - Aprocitentan 25 mg
Treatment: Drugs - Placebo

Experimental: Aprocitentan 25 mg DB - Part 1: Double-blind, randomized (1:1:1 ratio), parallel-group and placebo-controlled and lasts for 4 weeks. Subjects will receive aprocitentan 25 mg

Experimental: Aprocitentan 12.5 mg DB - Part 1: Double-blind, randomized (1:1:1 ratio), parallel-group and placebo-controlled and lasts for 4 weeks. Subjects will receive aprocitentan 12.5 mg

Placebo Comparator: Placebo DB - Part 1: Double-blind, randomized (1:1:1 ratio), parallel-group and placebo-controlled and lasts for 4 weeks. Subjects will receive placebo

Experimental: Aprocitentan 25 mg SB - Part 2: Single-blind and single-arm, lasts for 32 weeks. All subjects will receive aprocitentan 25 mg.

Experimental: Aprocitentan 25 mg DB-WD - Part 3: Double-blind withdrawal. Subjects will be re-randomized to aprocitentan 25 mg

Placebo Comparator: Placebo DB-WD - Part 3: Double-blind withdrawal. Subjects will be re-randomized to placebo.


Treatment: Drugs: Aprocitentan 12.5 mg
Tablet, oral use

Treatment: Drugs: Aprocitentan 25 mg
Tablet, oral use

Treatment: Drugs: Placebo
Matching placebo tablet

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to Week 4 of DB treatment in trough Sitting Systolic BP (SiSBP) measured by AOBPM
Timepoint [1] 0 0
From baseline to Week 4 after treatment initiation
Secondary outcome [1] 0 0
Change from Week 36 (i.e., start of DB-WD) to Week 40 in trough SiSBP as measured by AOBPM
Timepoint [1] 0 0
From week 36 to week 40
Secondary outcome [2] 0 0
Change from baseline to Week 4 of DB treatment in trough Sitting Diastolic BP (SiDBP) measured by AOBPM
Timepoint [2] 0 0
From baseline to Week 4
Secondary outcome [3] 0 0
Changes from baseline to Week 4 of DB treatment in 24-h mean SBP and DBP measured by ABPM
Timepoint [3] 0 0
From baseline to Week 4
Secondary outcome [4] 0 0
Change from Week 36 to Week 40 of DB-WD treatment in trough SiDBP measured by AOBPM
Timepoint [4] 0 0
From week 36 to week 40
Secondary outcome [5] 0 0
Changes from Week 36 to Week 40 of DB-WD treatment in 24-h mean SBP and DBP measured by ABPM
Timepoint [5] 0 0
From week 36 to week 40

Eligibility
Key inclusion criteria
Screening period:

- Signed and dated ICF prior to any study-mandated procedure;

- Male and female subjects; 18 years (or year of country specific majority) or older;

- Historical documentation in the subject's medical records on uncontrolled BP despite
at least 3 background antihypertensive medications within 1 year before screening
visit;

- Treated with at least 3 antihypertensive therapies of different pharmacological
classes including a diuretic for at least 4 weeks before the screening visit (Visit
1);

- Mean SiSBP = 140 mmHg measured by AOBPM;

- Women of childbearing potential are eligible only if the following applies;

- Negative pregnancy test at screening and at baseline (i.e., before randomization);

- Agreement to undertake pregnancy tests during the study and up to 30 days after
randomized study treatment discontinuation;

- Agreement to use methods of birth control from Screening up to at least 30 days after
randomized study treatment discontinuation.

Run-in period (RI):

- Switched to the standardized background antihypertensive therapy at least 4 weeks
before the first RI visit;

- Mean trough SiSBP = 140 mmHg as measured by AOBPM.

Randomization period:

- Stable dose of the standardized background antihypertensive therapy since start of the
RI period;

- Mean trough SiSBP = 140 mmHg measured by AOBPM.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Apparent/pseudo RHT due to white coat effect, medical inertia, poor therapeutic
adherence, or secondary causes of hypertension (except sleep apnea);

- Confirmed severe hypertension (grade 3) defined as SiSBP=180 mmHg and/or SiDBP=110
mmHg as measured by AOBPM at two different timepoints;

- Pregnant or lactating subjects;

- Clinically significant unstable cardiac disease in the opinion of the investigator;

- Severe renal insufficiency;

- N-terminal pro-brain natriuretic peptide (NT-proBNP) = 200 pg/mL;

- Any known factor, disease or clinically relevant medical or surgical conditions that,
in the opinion of the investigator, might put the subject at risk, interfere with
treatment compliance, study conduct or interpretation of the results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St. George Hospital, Dept. Renal Medicine - Kogarah
Recruitment hospital [2] 0 0
CCRE Clinical Trial Centre, SPHPM, Monash University - Caulfield
Recruitment hospital [3] 0 0
Curtin University, Faculty of Health Sciences, School of Public Health - Perth
Recruitment hospital [4] 0 0
Royal Perth Hospital Unit - The University of Western Australia - Perth
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3162 - Caulfield
Recruitment postcode(s) [3] 0 0
6008 - Perth
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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California
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Michigan
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Charleroi
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Brno
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Czechia
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Prague
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Czechia
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Praha 4
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Czechia
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Prerov
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Oulu
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Tampere
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Turku
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Kemerovo
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London
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Idorsia Pharmaceuticals Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen Biotech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to show the blood pressure lowering effect of aprocitentan, a new
drug, when added to other anti-hypertensive drugs of patients with difficult to control
(resistant) high blood pressure (hypertension), and to show that blood pressure reduction is
kept for long period of time.
Trial website
https://clinicaltrials.gov/show/NCT03541174
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Idorsia Pharmaceuticals Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trial Disclosure desk
Address 0 0
Country 0 0
Phone 0 0
+41588440000
Fax 0 0
Email 0 0
clinical-trials-diclosure@idorsia.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable