Health TrialsbyHealthPanel

A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients

ConditionHypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorHanmi Pharmaceutical Company Limited

About this trial

A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate the Efficacy and Safety of HGP2102 in patients with Essential Hypertension

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions

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

140mmHG≤sitSBP<180mmHg and 60mmHg≤sitDBP<110mmHg

Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions

Disqualifiers

Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg 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 hypertension patient or suspected to be

Trial design

Design model

Parallel

Treatments tested in this trial

  • HGP2102-1

    Drug

    Test drug

  • HGP2102-2

    Drug

    Test drug

  • RLD2209-1

    Drug

    Control drug

  • RLD2209-2

    Drug

    Control drug

Treatment groups

324 Participants
are divided into 3 treatment groups
Group A: Experimental1Experimental treatment 2 interventions
Group B: Experimental2Experimental treatment 1 intervention
Group C: Active ComparatorActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in 24 hours ambulatory systolic blood pressure

Time frame
baseline, 10 weeks

Secondary outcomes

1

Change from baseline in 24 hours ambulatory systolic blood pressure

Time frame
baseline, 4 weeks
2

Change from baseline in 24 hours ambulatory diastolic blood pressure

Time frame
baseline, 4 weeks, 10 weeks
3

Change from baseline in 24 hours ambulatory pulse pressure

Time frame
baseline, 4 weeks, 10 weeks
4

Change from baseline in diurnal ambulatory systolic blood pressure

Time frame
baseline, 4 weeks, 10 weeks

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Sevrance hosptalRecruiting03722, Seodaemun-gu, SeoulSouth Korea

Sponsors and contacts

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

Hanmi Pharmaceutical Company Limited

Lead sponsor

Source ClinicalTrials.gov
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