Essential Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: ACT-280778
* Drug: Placebo
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |