NCT05450601CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients
A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension
Source: ClinicalTrials.gov · Last updated 5 Mar 2024
Brief summary (registry, in English)
A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 249 (actual)
- First submitted
- 5 Jul 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 11 Dec 2023
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Diseases
- High blood pressure
- NCT number
- NCT05450601
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 249
- From 1 Sept 2022 to the primary completion date, 11 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Orthostatic hypotension with symptoms within 3 months prior to visit 1
Other illness
- Secondary hypertension patient or suspected to be
- Severe heart disease or severe neurovascular disease
- Severe or malignant retinopathy
- History of malignancy tumor
- History of autoimmune disease
- History of alcohol or drug abuse
Lab values
- Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus
- Severe renal diseases (eGFR\<30mL/min/1.73m2)
- Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
Other
- Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
- Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
- Clinically significant hematological finding
- Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L)
- Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L)
- Hypercalcemia(Ca ≥ 10.5mg/dL)
- Positive to pregnancy test, nursing mother, intention on pregnancy
- Considered by investigator as not appropriate to participate in the clinical study with other reason
Who the study is looking for
- Patients aged ≥ 19 years
- Patients who understands the process of clinical study and voluntarily signs a peer letter
- Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions
- Blood pressure medication taken patients: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
- Blood pressure medication free patients: 160mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
- Visit 2: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.