MedTrace Logo

Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension

NCT02603809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1659

Last updated 2022-11-23

Study results available
· View outcomes & findings →

Summary

The main objective will be to evaluate the dose-response of ACT-132577 (aprocitentan) on diastolic blood pressure (DBP) in participants with grade 1 or 2 essential hypertension.

Secondary objectives will be to evaluate the dose-response of ACT-132577 on: systolic blood pressure (SBP); control and response rate of blood pressure; 24-hour ambulatory blood pressure monitoring (ABPM) and to evaluate the safety and tolerability of a once daily oral regimen of 4 doses of ACT-132577.

Conditions

  • Essential Hypertension

Interventions

DRUG

Aprocitentan 5 mg

One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.

DRUG

Aprocitentan 10 mg

Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.

DRUG

Aprocitentan 25 mg

One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.

DRUG

Aprocitentan 50 mg

One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.

DRUG

Lisinopril 20 mg

One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan

DRUG

Placebo

One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • ClinicalTrials · Idorsia Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-14
Primary Completion
2017-02-28
Completion
2017-04-07
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Israel
  • Puerto Rico

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 NCT02603809 on ClinicalTrials.gov