Essential Hypertension
Conditions
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.
Interventions
DRUGACT-280778
10 mg once daily for 28 ± 2 days
DRUGPlacebo
Placebo oral capsules matching ACT-280778
DRUGAmlodipine
10 mg once daily for 28 ± 2 days
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean(c) trough(d) SiDBP | Baseline to day 28 | Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean trough SiSBP. | Baseline to Day 28 | Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP. |
Countries
Israel, Serbia
Outcome results
None listed