Essential Hypertension

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.

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