Clinical Study to Explore the Effects of Actelion's Latest Endothelin Receptor Antagonist (ERA) - at Different Dose Strengths - on the Efficacy, Safety and Tolerability in Subjects With Essential Hypertension
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 2/3/2019 |
Start Date: | January 25, 2016 |
End Date: | March 31, 2017 |
Multi-center, Double-blind, Double-dummy, Randomized, Placebo- and Active-reference, Parallel Group, Phase 2 Dose-finding Study With Actelion's Latest Endothelin Receptor Antagonist (ERA) in Subjects With Essential Hypertension (Grade 1 and 2)
The main objective of the study is to explore the effects of ERA - at different dose
strengths - on the efficacy, safety and tolerability in subjects with essential hypertension
strengths - on the efficacy, safety and tolerability in subjects with essential hypertension
Inclusion Criteria:
- Signed informed consent prior to any study-mandated procedure
- Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive
treatment(s)
- No contra-indication to stop (according to label) anti-hypertensive treatment(s)
- Women of childbearing potential must have a negative pregnancy test and use of
reliable methods of contraception
Exclusion Criteria:
- Severe hypertension (grade 3): mean sitting systolic/diastolic BP (SiSBP/SiDBP;
measured by OBPM) ≥ 180/110 mmHg, respectively.
- Secondary hypertension
- Known hypertensive retinopathy greater than Keith-Wagener Grade 2
- Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary
artery bypass graft within 12 months prior to randomization
- Unstable angina within 6 months prior to randomization
- Heart failure New York Heart Association class III and IV
- Valvular defects (such as severe aortic or mitral valve disease) and/or
hemodynamically relevant rhythm disturbances
- Clinical evidence of cerebrovascular insufficiency or a cerebrovascular accident
within 6 months prior to randomization.
- Subjects working night shifts
- Body mass index < 20 kg/m2 or > 40 kg/m2
- Treatment with any medication which may affect BP (e.g., treatment of psychiatric
diseases, ophthalmic preparations)
- Treatment with strong cytochrome P450 3A4 (CYP3A4) isoenzyme inhibitors or inducers
- Treatment with guanethidine and/or mineralocorticoid receptor antagonists within 1
month prior to Screening (Visit 1)
- Treatment with another investigational treatment within 1 month prior to Screening
(Visit 1)
- Any circumstances or conditions, which, in the opinion of the investigator, may affect
full participation in the study or compliance with the protocol
We found this trial at
72
sites
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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