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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 (PRECISION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541174
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : July 16, 2020
Sponsor:
Collaborator:
Janssen Biotech, Inc.
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Resistant Hypertension Drug: Aprocitentan 12.5 mg Drug: Aprocitentan 25 mg Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

SB placebo run-in/randomized with 3 parts:

Part 1: double-blind (DB), randomized to aprocitentan 12.5 mg, aprocitentan 25 mg or placebo; Part 2: single blind (SB) aprocitentan 25 mg; Part 3: double-blind re-randomized (DB-WD) to aprocitentan 25 mg or placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : February 8, 2021
Estimated Study Completion Date : February 8, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Aprocitentan 25 mg
Tablet, oral use
Other Name: ACT-132577
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
 Drug: Aprocitentan 12.5 mg
Tablet, oral use
Other Name: ACT-132577
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
 Drug: Placebo
Matching placebo tablet
Experimental: Aprocitentan 25 mg SB
Part 2: Single-blind and single-arm, lasts for 32 weeks. All subjects will receive aprocitentan 25 mg.
 Drug: Aprocitentan 25 mg
Tablet, oral use
Other Name: ACT-132577
Experimental: Aprocitentan 25 mg DB-WD
Part 3: Double-blind withdrawal. Subjects will be re-randomized to aprocitentan 25 mg
 Drug: Aprocitentan 25 mg
Tablet, oral use
Other Name: ACT-132577
Placebo Comparator: Placebo DB-WD
Part 3: Double-blind withdrawal. Subjects will be re-randomized to placebo.
 Drug: Placebo
Matching placebo tablet


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to Week 4 of DB treatment in trough Sitting Systolic BP (SiSBP) measured by AOBPM [ Time Frame: From baseline to Week 4 after treatment initiation ]

Secondary Outcome Measures :
  1. Change from Week 36 (i.e., start of DB-WD) to Week 40 in trough SiSBP as measured by AOBPM [ Time Frame: From week 36 to week 40 ]
  2. Change from baseline to Week 4 of DB treatment in trough Sitting Diastolic BP (SiDBP) measured by AOBPM [ Time Frame: From baseline to Week 4 ]
  3. Changes from baseline to Week 4 of DB treatment in 24-h mean SBP and DBP measured by ABPM [ Time Frame: From baseline to Week 4 ]
  4. Change from Week 36 to Week 40 of DB-WD treatment in trough SiDBP measured by AOBPM [ Time Frame: From week 36 to week 40 ]
  5. Changes from Week 36 to Week 40 of DB-WD treatment in 24-h mean SBP and DBP measured by ABPM [ Time Frame: From week 36 to week 40 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 for at least 1 week before the end of the RI period;
  • Mean trough SiSBP ≥ 140 mmHg measured by AOBPM.

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 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 subject at risk, interfere with treatment compliance, study conduct or interpretation of the results.
  • Treatment with any medication which may affect 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541174


Contacts
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Contact: Clinical Trial Disclosure desk +18566613721 clinical-trials-diclosure@idorsia.com
Contact: Clinical Trial Disclosure desk +41588441977 clinical-trials-diclosure@idorsia.com

Locations
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Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Janssen Biotech, Inc.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
More Information
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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03541174    
Other Study ID Numbers: ID-080A301
2017-004393-33 ( EudraCT Number )
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases