A Study to Investigate Efficacy and Safety of a TCA108 in Participants ≥18 Years With Uncontrolled Hypertension
ConditionHypertension
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMS
About this trial
The purpose of this study if to evaluate the efficacy and safety of TCA108 in the treatment of hypertension.
Eligibility criteria
Qualifiers
Participant must be 18 years of age or older at the time of signing the informed consent.
Participants with a diagnosis of arterial hypertension presenting with SBP ≥ 140 mmHg and ≤ 170 mmHg and DBP ≥ 90 mmHg and ≤ 110 mmHg, confirmed by triplicate measurements from the reference arm at the screening visit.
Participants with uncontrolled hypertension, confirmed by ambulatory blood pressure monitoring (ABPM) performed during the screening period, defined as SBP ≥ 130 mmHg and DBP ≥ 80 mmHg.
Participant is male or female at birth.
Disqualifiers
Any clinical observation (clinical/physical assessment) or laboratory condition interpreted by the investigator as posing a risk to the participant's involvement in the clinical trial, or the presence of uncontrolled chronic disease(s).
Known contraindication or history of hypersensitivity or intolerance to any components of the medications used during the clinical trial.
Essential hypertension with DBP > 110 mmHg and/or SBP > 170 mmHg.
Participants who have experienced any cardiovascular event (acute myocardial infarction, unstable angina, newly diagnosed stable angina, stroke, unstable congestive heart failure requiring treatment adjustment), undergone revascularization procedure, or vascular surgery within the 6 (six) months prior to screening.
Trial design
Treatments tested in this trial
- TCA108
- Bramicar HCT
- Micardis Anlo
Treatment groups
400 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov