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

Idorsia Pharmaceuticals Ltd.18 sites in 2 countries196 target enrollmentFebruary 2011

ConditionsEssential Hypertension

InterventionsACT-280778 Placebo Amlodipine

DrugsACT-280778 Placebo Amlodipine

Overview

Phase: Phase 2
Intervention: ACT-280778
Conditions: Essential Hypertension
Sponsor: Idorsia Pharmaceuticals Ltd.
Enrollment: 196
Locations: 18
Primary Endpoint: Change in mean(c) trough(d) SiDBP
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

February 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Idorsia Pharmaceuticals Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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