A Study to Investigate Efficacy and Safety of a TCA108 in Participants ≥18 Years With Uncontrolled Hypertension

Sponsor
EMS
Study ID
NCT07030101
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TCA108 — DRUG
    TCA108
  • Bramicar HCT — DRUG
    Bramicar HCT
  • Micardis Anlo — DRUG
    Micardis Anlo

Study Details

The purpose of this study if to evaluate the efficacy and safety of TCA108 on treatment of hypertension.

Key Dates

First listed
Jun 19, 2025
Start date
Nov 30, 2026
Status verified
Jul 2026
Primary completion
May 31, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bramicar HCT
    The participants must take 1 tablet per day
  • Experimental: TCA108
    The participants must take 1 tablet per day
  • Active Comparator: Micardis Anlo
    The participants must take 1 tablet per day

Primary Outcome Measure

Mean change from baseline systolic blood pressure (SBP) after 12 weeks of treatment [ Time Frame: 12 weeks ]

Central Contacts

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