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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03541174
Registration number
NCT03541174
Ethics application status
Date submitted
17/05/2018
Date registered
30/05/2018
Date last updated
21/03/2023
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
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Scientific title
Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)
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Secondary ID [1]
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2017-004393-33
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Secondary ID [2]
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ID-080A301
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Universal Trial Number (UTN)
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Trial acronym
PRECISION
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Aprocitentan 12.5 mg
Treatment: Drugs - Aprocitentan 25 mg
Treatment: Drugs - Placebo
Experimental: Aprocitentan 25 mg in Part 1 (double-blind) - Participants will receive aprocitentan 25 mg, orally, once daily in the morning for 4 weeks.
Experimental: Aprocitentan 12.5 mg in Part 1 (double-blind) - Participants will receive aprocitentan 12.5 mg, orally, once daily in the morning for 4 weeks.
Placebo Comparator: Placebo in Part 1 (double-blind) - Participants will receive placebo (matching aprocitentan), orally, once daily in the morning for 4 weeks.
Experimental: Aprocitentan 25 mg in Part 2 (single-blind, single arm) - After 4-weeks in the double-blind randomized part (Part 1), participants will received 25 mg aprocitentan, orally, once daily in the morning for 32 weeks.
Experimental: Aprocitentan 25 mg in Part 3 (double-blind withdrawal) - After 32-weeks in the single-blind, single-arm part (Part 2), participants will be re-randomized and receive aprocitentan 25 mg, orally, once daily in the morning for 12 weeks.
Placebo Comparator: Placebo in Part 3 (double-blind withdrawal) - After 32-weeks in the single-blind, single-arm part (Part 2), participants will be re-randomized and receive placebo (matching aprocitentan), orally, once daily in the morning for 12 weeks.
Treatment: Drugs: Aprocitentan 12.5 mg
Tablet, oral use
Treatment: Drugs: Aprocitentan 25 mg
Tablet, oral use
Treatment: Drugs: Placebo
Matching placebo tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Automated Office Blood Pressure Measurement
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Assessment method [1]
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Changes from baseline to Week 4 in mean trough SiSBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). A negative change indicates a decrease in SiSBP from baseline.
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Timepoint [1]
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Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1)
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Secondary outcome [1]
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Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Unattended Automated Office Blood Pressure Measurement
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Assessment method [1]
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Changes from double-blind withdrawal baseline (Week 36) to Week 40 in mean trough SiSBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). A negative change indicates a decrease in SiSBP from baseline.
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Timepoint [1]
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Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40
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Secondary outcome [2]
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Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure Measurement
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Assessment method [2]
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Changes from baseline to Week 4 in mean trough SiDBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. A negative change indicates a decrease in SiDBP from baseline.
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Timepoint [2]
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Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1)
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Secondary outcome [3]
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Changes From Baseline to Week 4 of Double-blind Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring
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Assessment method [3]
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ABPM devices were provided to each site by the central blood pressure laboratory. On the first day after all visit assessments were performed, the ABPM device (Mobil-O-Graph NG) was fitted to the participant. The following day (i.e., second day), the participant came back to site to have the ABPM device removed. ABPM data collected over the 24-hours was electronically transferred to the central BP laboratory. Systolic blood pressure and diastolic blood pressure were measured at predetermined times every 20 minutes from 06:00 to 21:59, and every 30 minutes from 22:00 to 05:59. For each participant and at each visit (baseline and Week 4) the 24-hour mean SBP (or DBP) was calculated from the area under the SBP (or DBP) time curve and divided by the time span. A negative change indicates a decrease in 24-hour mean systolic / diastolic blood pressure from baseline.
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Timepoint [3]
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Pre-dose Day 1 (Part 1 double-blind randomized baseline) and Week 4 (End of double-blind randomized part 1)
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Secondary outcome [4]
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Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 of Double-blind-withdrawal (DB-WD) Treatment in Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure
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Assessment method [4]
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Changes from double-blind withdrawal (Week 36) to Week 40 in mean trough SiDBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). A negative change indicates a decrease in SiDBP from baseline.
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Timepoint [4]
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Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40
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Secondary outcome [5]
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Changes From Double-blind Withdrawal Baseline (Week 36) to Week 40 of Double-blind-withdrawal (DB-WD) Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring
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Assessment method [5]
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ABPM devices were provided to each site by the central blood pressure laboratory. On the first day after all visit assessments were performed, the ABPM device (Mobil-O-Graph NG) was fitted to the participant. The following day (i.e., second day), the participant came back to site to have the ABPM device removed. ABPM data collected over the 24-hours was electronically transferred to the central BP laboratory. Systolic blood pressure and diastolic blood pressure were measured at predetermined times every 20 minutes from 06:00 to 21:59, and every 30 minutes from 22:00 to 05:59. For each participant and at each visit (the double-blind withdrawal baseline [Week 36] and the week 40) the 24-hour mean SBP (or DBP) was calculated from the area under the SBP (or DBP) time curve. A negative change indicates a decrease in 24-hour mean systolic / diastolic blood pressure from baseline.
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Timepoint [5]
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From Week 36 (Part 3 double-blind-withdrawal baseline) and Week 40
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Eligibility
Key inclusion criteria
Screening period:
- Signed and dated informed consent form (ICF) prior to any study-mandated procedure;
- Male and female participants; 18 years (or year of country specific majority) or
older;
- Historical documentation in the participant's medical records on uncontrolled blood
pressure despite at least 3 background antihypertensive medications within 1 year
before screening visit;
- Treated with at least 3 antihypertensive therapies of different pharmacological
classes for at least 4 weeks before the screening visit (Visit 1);
- Mean Sitting Systolic Blood Pressure (SiSBP) greater or equal to 140 mmHg measured by
Automated Office Blood Pressure Measurement (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 greater than or equal to140 mmHg as measured by AOBPM.
Randomization period:
- Stable dose of the standardized background antihypertensive therapy for at least 1
week before the end of the RI period;
- Mean trough SiSBP greater than or equal to 140 mmHg measured by AOBPM.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Apparent/pseudo Resistant Hypertension (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 greater than or equal to 180
mmHg and/or Sitting Diastolic Blood Pressure (SiDBP) greater than or equal to 110 mmHg
as measured by AOBPM at two different timepoints;
- Pregnant or lactating participants;
- Clinically significant unstable cardiac disease at screening or in the past in the
opinion of the investigator (exclusion of participants with significant or potential
unstable cardiac disease);
- Severe renal insufficiency;
- Any known factor, disease or clinically relevant medical or surgical conditions that,
in the opinion of the investigator, might put the participant at risk, interfere with
treatment compliance, study conduct or interpretation of the results.
- Treatment with any medication which may affect blood pressure (BP) and/or treatment
with high dose of loop diuretics (i.e., furosemide greater than 80 mg/day, or
equivalent dosage of other loop diuretics).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/04/2022
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Sample size
Target
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Accrual to date
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Final
730
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Renal Research - Gosford
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Recruitment hospital [2]
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Westmead Hospital Department of Renal Medicine - Sydney
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Recruitment hospital [3]
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment hospital [4]
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Hypertension & Kidney Disease / Huma Neurotransmitter Laboratory - Melbourne
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Recruitment hospital [5]
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Curtin University, Faculty of Health Sciences, School of Public Health - Bentley
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Recruitment hospital [6]
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Royal Perth Hospital Unit - The University of Western Australia - Perth
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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2145 - Sydney
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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6102 - Bentley
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Recruitment postcode(s) [5]
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6000 - Perth
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Recruitment outside Australia
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Alabama
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California
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Tyumen
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Vinnytsya
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Ukraine
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Zhytomyr
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United Kingdom
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Aberdeen
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United Kingdom
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Edinburgh
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Idorsia Pharmaceuticals Ltd.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Janssen Biotech, Inc.
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Ethics approval
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Summary
Brief summary
The goal of this clinical trial 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03541174
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Trial related presentations / publications
Daskalopoulou SS, Khan NA, Quinn RR, Ruzicka M, McKay DW, Hackam DG, Rabkin SW, Rabi DM, Gilbert RE, Padwal RS, Dawes M, Touyz RM, Campbell TS, Cloutier L, Grover S, Honos G, Herman RJ, Schiffrin EL, Bolli P, Wilson T, Feldman RD, Lindsay MP, Hemmelgarn BR, Hill MD, Gelfer M, Burns KD, Vallee M, Prasad GV, Lebel M, McLean D, Arnold JM, Moe GW, Howlett JG, Boulanger JM, Larochelle P, Leiter LA, Jones C, Ogilvie RI, Woo V, Kaczorowski J, Trudeau L, Bacon SL, Petrella RJ, Milot A, Stone JA, Drouin D, Lamarre-Cliche M, Godwin M, Tremblay G, Hamet P, Fodor G, Carruthers SG, Pylypchuk G, Burgess E, Lewanczuk R, Dresser GK, Penner B, Hegele RA, McFarlane PA, Sharma M, Campbell NR, Reid D, Poirier L, Tobe SW; Canadian Hypertension Education Program. The 2012 Canadian hypertension education program recommendations for the management of hypertension: blood pressure measurement, diagnosis, assessment of risk, and therapy. Can J Cardiol. 2012 May;28(3):270-87. doi: 10.1016/j.cjca.2012.02.018.
Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005 Feb 8;111(5):697-716. doi: 10.1161/01.CIR.0000154900.76284.F6.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Idorsia Pharmaceuticals Ltd.
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03541174
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