Health TrialsbyHealthPanel

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 on treatment of hypertension.

Eligibility criteria

This trial does not accept healthy volunteers

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 ≤ 179 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 > 179 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

Design model

Parallel

Treatments tested in this trial

  • TCA108

    Drug

    TCA108

  • Bramicar HCT

    Drug

    Bramicar HCT

  • Micardis Anlo

    Drug

    Micardis Anlo

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Bramicar HCTActive comparator 1 intervention
Group B: TCA108Experimental treatment 1 intervention
Group C: Micardis AnloActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change from baseline systolic blood pressure (SBP) after 12 weeks of treatment

Time frame
12 weeks

Secondary outcomes

1

Proportion of participants with blood pressure <130/80 mmHg after 4, 8 and 12 weeks of treatment

Time frame
12weeks
2

Proportion of participants with systolic blood pressure (SBP) <130 mmHg or a change from baseline SBP of at least a 10 mmHg decrease after 4, 8 and 12 weeks of treatment

Time frame
12 weeks
3

Mean change from baseline diastolic blood pressure (DBP) after 4, 8 and 12 weeks of treatment

Time frame
12 weeks
4

Proportion of participants with diastolic blood pressure (DBP) <80 mmHg or a change from baseline DBP of at least a 5 mmHg decrease after 4, 8 and 12 weeks of treatment

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: