Status:
COMPLETED
Essential Hypertension
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT01264692
Start Date
February 1 2011
End Date
February 1 2012
Last Update
September 27 2018
Active Locations (18)
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1
Clinical Investigative Site 4000
Afula, Israel, 18101
2
Clinical Investigative Site 1003
Ashkelon, Israel, 78278
3
Clinical Investigative Site 1008
Beersheba, Israel, 84101
4
Clinical Investigative Site 1004
Giv‘atayim, Israel, 53583