Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes
Idorsia
Leitung: Prof. Dr. Michael Böhm

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)
    06841 - 16 - 21202
    06841 - 16 - 21415
    Neurath Barbara
    Dr.
    Wachter, 
    Angelika
    Stellv. Leitung Studienzentrum (Geb. 24)
    06841 - 16 - 23318
    06841 - 16 - 21415
    Wachter Angelika