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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HCP1803-3

    Drug

    Test drug

  • HCP1803-4

    Drug

    Test drug

  • RLD2001-1

    Drug

    Control drug

  • RLD2001-2

    Drug

    Control drug

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: HCP1803-4Experimental treatment 2 interventions
Group B: RLD2001-2Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in sitting systolic blood pressure

Time frame
Baseline, 10 weeks

Secondary outcomes

1

Change from baseline in sitting systolic blood pressure

Time frame
Baseline, 2 weeks, 6 weeks
2

Change from baseline in sitting diastolic blood pressure

Time frame
Baseline, 2 weeks, 6 weeks, 10 weeks
3

Proportion of subjects achieving blood pressure control (sitSBP)

Time frame
2 weeks, 6 weeks, 10 weeks
4

Proportion of subjects achieving blood pressure control (sitSBP, sitDBP)

Time frame
2 weeks, 6 weeks, 10 weeks

Other outcomes

Sponsors and contacts

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

Hanmi Pharmaceutical Company Limited

Lead sponsor

Source ClinicalTrials.gov

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