A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

ConditionHypertension
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorHanmi Pharmaceutical Company Limited

About this trial

A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

Eligibility criteria

Qualifiers

Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions

mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1

140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1

Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2

Disqualifiers

Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1

Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1

Orthostatic hypotension with symptoms within 3 months prior to visit 1

Secondary hypertensive patient or suspected to be

Trial design

Treatments tested in this trial

  • HCP1803-3
  • HCP1803-4
  • RLD2001-1
  • RLD2001-2

Treatment groups

256 Participants
are divided into 2 treatment groups