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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

NCT03541174 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2023-03-21

Study results available
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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.

Conditions

  • Resistant Hypertension

Interventions

DRUG

Aprocitentan 12.5 mg

Tablet, oral use

DRUG

Aprocitentan 25 mg

Tablet, oral use

DRUG

Placebo

Matching placebo tablet

Sponsors & Collaborators

  • Janssen Biotech, Inc.

    collaborator INDUSTRY

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2021-05-14
Completion
2022-04-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541174 on ClinicalTrials.gov