Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
196 participants
INTERVENTIONAL
2011-02-28
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment A
ACT-280778
ACT-280778
10 mg once daily for 28 ± 2 days
Treatment B
Placebo
Placebo
Placebo oral capsules matching ACT-280778
Treatment C
Amlodipine
Amlodipine
10 mg once daily for 28 ± 2 days
Interventions
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ACT-280778
10 mg once daily for 28 ± 2 days
Placebo
Placebo oral capsules matching ACT-280778
Amlodipine
10 mg once daily for 28 ± 2 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kasra Shakeri-Nejad, MD, PhD
Role: STUDY_DIRECTOR
Actelion
Locations
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Clinical Investigative Site 4000
Afula, , Israel
Clinical Investigative Site 1003
Ashkelon, , Israel
Clinical Investigative Site 1008
Beersheba, , Israel
Clinical Investigative Site 1004
Giv‘atayim, , Israel
Clinical Investigative Site 1009
Holon, , Israel
Clinical Investigative Site 1000
Jerusalem, , Israel
Clinical Investigative Site 1006
Nazareth, , Israel
Clinical Investigative Site 1007
Nazareth, , Israel
Clinical Investigative Site 1005
Safed, , Israel
Clinical Investigative Site 1010
Tel Aviv, , Israel
Clinical Investigative Site 1012
Tel Litwinsky, , Israel
Clinical Investigative Site 3001
Belgrade, , Serbia
Clinical InvestigativeSite 3003
Belgrade, , Serbia
Clinical Investigative Site 4001
Belgrade, , Serbia
Clinical Investigative Site 3004
Belgrade, , Serbia
Clinical Investigative Site 3000
Niška Banja, , Serbia
Clinical Investigative Site 4002
Pančevo, , Serbia
Clinical Investigative Site 3002
Zemun, , Serbia
Countries
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Other Identifiers
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AC-067A201
Identifier Type: -
Identifier Source: org_study_id
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