Idorsia
(EudraCT 2017-004393-33)
INCLUSION Criteria (gekürzt)
The complete list of inclusion criteria is provided in the core text. The main criteria per study period are:
Screening criteria
- This study will enroll adult male and female subjects ≥18 years oldwith RHT defined as:
- Mean sitting systolic BP (SiSBP) ≥140 mmHg measured byunattended automated office blood pressure measurement(AOBPM) despite a background antihypertensive medication of atleast 3 different pharmacological classes (including a diuretic) forat least 4 weeks before the screening visit (Visit 1). Beta-blockersare not counted as background antihypertensive medication.
RI entry criteria
- Subjects with a confirmed diagnosis of RHT who are onstandardized background antihypertensive therapy for at least4 weeks will enter the placebo RI period if their mean trough SiSBPis ≥140 mmHg as measured by AOBPM.
Randomization criteria
- Subjects who completed the RI period without changing the dose ofthe standardized background antihypertensive therapy and whohave a mean trough SiSBP ≥140 mmHg as measured by AOBPMwill be randomized.
EXCLUSION Criteria (gekürzt)
The complete list of exclusion criteria is provided in the core text. The main exclusion criteria are:
- Apparent/pseudo RHT due to white coat effect, medical inertia, poor therapeutic adherence, or secondary causes of hypertension (except sleep apnea)
- Confirmed severe hypertension (grade 3 ):
meanSiSBP ≥180 mmHg and/or sitting diastolic blood pressure(SiDBP) ≥110 mmHg, measured by AOBPM at two different time points.
Ansprechpartner im Studienzentrum
Neurath,
Barbara
Leitung Studienambulanz (Geb. 24)
Dr.
Wachter,
Angelika
Stellv. Leitung Studienzentrum (Geb. 24)