Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Idorsia Pharmaceuticals Ltd.
Participation in the study is planned to last up to 18 weeks. A single-blind placebo run-in period of 4 to 6 weeks after which participants will be randomized into a double-blind treatment period of 8 weeks and a washout and follow-up period ending with an end-of-study visit approximately 12 weeks after randomization.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent prior to any study-mandated procedure
No contra-indication to stop (according to label) anti-hypertensive treatment(s) at screening
Mild-to-moderate essential hypertension with or without ongoing anti-hypertensive treatment(s):
\-- Mean (of 5 measurements) sitting diastolic blood pressure (SiDBP) ≥ 90 to \< 110 mmHg measured by office blood pressure measurements (OBPM).
Women of childbearing potential must have a negative pregnancy test and use of reliable methods of contraception
You may not be if
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
