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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.

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date July 16, 2020
Actual Study Start Date  ICMJE June 18, 2018
Estimated Primary Completion Date February 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Resistant Hypertension
Intervention  ICMJE
  • Drug: Aprocitentan 12.5 mg
    Tablet, oral use
    Other Name: ACT-132577
  • Drug: Aprocitentan 25 mg
    Tablet, oral use
    Other Name: ACT-132577
  • Drug: Placebo
    Matching placebo tablet
Study Arms  ICMJE
  • 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
    Intervention: Drug: 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
    Intervention: Drug: 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
    Intervention: Drug: Placebo
  • Experimental: Aprocitentan 25 mg SB
    Part 2: Single-blind and single-arm, lasts for 32 weeks. All subjects will receive aprocitentan 25 mg.
    Intervention: Drug: Aprocitentan 25 mg
  • Experimental: Aprocitentan 25 mg DB-WD
    Part 3: Double-blind withdrawal. Subjects will be re-randomized to aprocitentan 25 mg
    Intervention: Drug: Aprocitentan 25 mg
  • Placebo Comparator: Placebo DB-WD
    Part 3: Double-blind withdrawal. Subjects will be re-randomized to placebo.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 8, 2021
Estimated Primary Completion Date February 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trial Disclosure desk +18566613721 clinical-trials-diclosure@idorsia.com
Contact: Clinical Trial Disclosure desk +41588441977 clinical-trials-diclosure@idorsia.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   China,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Netherlands,   Poland,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03541174
Other Study ID Numbers  ICMJE ID-080A301
2017-004393-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Idorsia Pharmaceuticals Ltd.
Study Sponsor  ICMJE Idorsia Pharmaceuticals Ltd.
Collaborators  ICMJE Janssen Biotech, Inc.
Investigators  ICMJE
Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
PRS Account Idorsia Pharmaceuticals Ltd.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP