Essential Hypertension (REDUCE-1)

A Multi-center, Double-blind, Randomized, Placebo- and Active-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of 10 mg of ACT-280778 in Patients With Mild to Moderate Essential Hypertension

The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral administration of ACT 280778 on DBP compared to placebo after 28 days.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: ACT-280778; Drug: Placebo; Drug: Amlodipine

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 18101
    • Clinical Investigative Site 4000
  • Ashkelon, Israel, 78278
    • Clinical Investigative Site 1003
  • Beer Sheva, Israel, 84101
    • Clinical Investigative Site 1008
  • Givatayim, Israel, 53583
    • Clinical Investigative Site 1004
  • Holon, Israel, 58100
    • Clinical Investigative Site 1009
  • Jerusalem, Israel, 91004
    • Clinical Investigative Site 1000
  • Nazareth, Israel, 16100
    • Clinical Investigative Site 1006
  • Nazareth, Israel, 16100
    • Clinical Investigative Site 1007
  • Safed, Israel, 13100
    • Clinical Investigative Site 1005
  • Tel Aviv, Israel, 66872
    • Clinical Investigative Site 1010
  • Tel-Hashomer, Israel, 52621
    • Clinical Investigative Site 1012
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Investigative Site 3001
  • Belgrade, Serbia, 11000
    • Clinical InvestigativeSite 3003
  • Belgrade, Serbia, 11040
    • Clinical Investigative Site 4001
  • Belgrade, Serbia, 11080
    • Clinical Investigative Site 3004
  • Niska Banja, Serbia, 18205
    • Clinical Investigative Site 3000
  • Pancevo, Serbia, 26000
    • Clinical Investigative Site 4002
  • Zemun, Serbia, 11080
    • Clinical Investigative Site 3002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females aged 18 to 75 years (inclusive) at screening.
• Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
• 12-lead ECG without clinically relevant abnormalities measured at screening.
• Clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
• Signed informed consent in the local language prior to any study-mandated procedure

Exclusion Criteria:

• Mean SBP > 180 mmHg.
• Severe, malignant, or secondary hypertension.
• Episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
• E6 Severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
• Angina pectoris within 6 months prior to enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; ACT-280778	Drug: ACT-280778; 10 mg once daily for 28 ± 2 days
Placebo Comparator: Treatment B; Placebo	Drug: Placebo; Placebo oral capsules matching ACT-280778
Other: Treatment C; Amlodipine	Drug: Amlodipine; 10 mg once daily for 28 ± 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean(c) trough(d) SiDBP	Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP.	Baseline to day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean trough SiSBP.	Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP.	Baseline to Day 28

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Investigators: Study Director: Kasra Shakeri-Nejad, MD, PhD, Actelion

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (Estimate): December 22, 2010

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: AC-067A201