Clinical trial NCT04830449: Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients
Official title: A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Losartan
Chlorthalidone
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate of efficacy and safety of HCP1904-2 and RLD2001-2 alone in patients with essential hypertension inadequately controlled on RLD2001-2 monotherapy.

Detailed description: A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients

Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years of age
2. Patients who understands the process of clinical study and voluntarily signs a peer letter
3. Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions

   * Blood pressure medication taken patients: 130mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
   * Blood pressure medication free patients: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg
4. Visit2: 140mmHg ≤ sitSBP\<180mmHg, sitDBP\<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP \<180mmHg, sit DBP \< 110mmHg

Exclusion Criteria:

* Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP
* Orthostatic hypotension with symptoms within 3months of visit 1
* Secondary hypertensive patient or suspected to be
* Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
* Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
* Severe heart disease or severe neurovascular disease
* Severe or malignant retinopathy
* Clinically significant hematological finding
* Severe renal diseases (eGFR\<30mL/min/1.73m2)
* Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
* Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
* Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
* 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 othe reason

Primary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure(mmHg)
timeFrame: Week 8
Secondary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure(mmHg)
timeFrame: Week 4
measure: Change from baseline in mean sitting diastolic blood pressure(mmHg)
timeFrame: Week 4,8
measure: Change from baseline in mean pulse blood pressure(mmHg)
timeFrame: Week 4,8
measure: Responder rate
timeFrame: Week 4, 8
measure: target blood pressure reach rate
timeFrame: Week 4, 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: