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

Conditions

• Resistant Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aprocitentan 12.5 mg — DRUG
  Tablet, oral use
• Aprocitentan 25 mg — DRUG
  Tablet, oral use
• Placebo — DRUG
  Matching placebo tablet

Study Details

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.

Key Dates

Start date

Jun 18, 2018

Status verified

Mar 2023

Primary completion

May 14, 2021

Completion

Apr 25, 2022

Study Design

Enrollment

730 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

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 [ Time Frame: Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1) ]

Locations (41)

Find similar trials in Alexander City, AL

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