Not yet recruiting NCT07660796

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

Phase III Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: HCP1803-3, HCP1803-4, RLD2001-1, RLD2001-2.
Who it may be relevant to: Registry conditions: Hypertension. Basic parameters: from 19 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: South Korea
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension

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

Detailed description

A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HCP1803-4 in patients with essential hypertension

Change from baseline in sitting systolic blood pressure [Time frame: Baseline, 10 weeks]

Secondary outcome measures (8)

Change from baseline in sitting systolic blood pressure [Time frame: Baseline, 2 weeks, 6 weeks]
Change from baseline in sitting diastolic blood pressure [Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks]
Proportion of subjects achieving blood pressure control (sitSBP) [Time frame: 2 weeks, 6 weeks, 10 weeks]
Proportion of subjects achieving blood pressure control (sitSBP, sitDBP) [Time frame: 2 weeks, 6 weeks, 10 weeks]
Blood pressure response rate (sitSBP) [Time frame: 2 weeks, 6 weeks, 10 weeks]
Blood pressure response rate (sitSBP, sitDBP) [Time frame: 2 weeks, 6 weeks, 10 weeks]
Treatment response rate [Time frame: 2 weeks, 6 weeks, 10 weeks]
Change from baseline in pulse pressure [Time frame: Baseline, 2 weeks, 6 weeks, 10 weeks]

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

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
Clinically significant hematological finding
Severe heart disease or severe neurovascular disease
Moderate or malignant retinopathy
Uncontrolled diabetes mellitus or type I diabetes mellitus
Active gout or hyperuricemia
Severe renal diseases
Severe or active hepatopathy
Hypokalemia or Hyperkalemia
Hyponatremia or Hypernatremia
Hypercalcemia
History of malignancy tumor
History of autoimmune disease
History of alcohol or drug abuse
Positive to pregnancy test, nursing mother, intention on pregnancy
Considered by investigator as not appropriate to participate in the clinical study with other reason

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

South Korea · 1 center

NCT: NCT07660796 · HM-APOLLO-303