Last updated: November 10, 2020
Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Overall Status: Active - Recruiting
Phase
N/A
Condition
High Blood Pressure (Hypertension)
Williams Syndrome
High Blood Pressure (Hypertension - Pediatric)
Treatment
N/AClinical Study ID
NCT04554303
AG-C1908
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with essential hypertension and diagnosed with stage 1-2 hypertension inaccordance with the 2019 Korean Society of Hypertension criteria (SBP ≥ 140 mmHg orDBP ≥ 90 mmHg)
- Where a subject and his/her spouse (partner) have agreed to use medically acceptablecontraceptives in the following during participation in this clinical study:
- Use of intrauterine device with proven failure rate of pregnancy;
- Simultaneous use of blocking contraception and spermicide;
- Has had a vasectomy;
- Has had a salpingectomy, tubal ligation, or hysterectomy;
- Those who have made voluntary decisions to participate in this clinical study and haveconsented to the Informed Consent Form in writing;
- Those who are able to understand and follow instructions and participate throughoutthe entire clinical study
Exclusion
Exclusion Criteria:
- Patients with uncontrolled, high-risk hypertension (SBP≥180mm Hg and DBP≥110mm Hg);
- Those who have a history of secondary hypertension and any history of suspectedsecondary hypertension (aortic congestion, hyperaldosteronism, renal artery stenosis,Cushing's disease, chromaffinoma, polycystic renal disease, etc.);
- Those who fall under one or more of the following items that may cause edema withoutunderlying diseases:
- Those who have been diagnosed with myocardial infarction or heart failure within 6 months of screening;
- Those who have been diagnosed with a cerebrovascular accident (CVA) within 6months of screening;
- Patients with renal failure requiring dialysis or those with edema caused byrenal dysfunction (renal salt retention);
- Those who have uncontrolled diabetes (HbA1c> 10.0%) or diabetic edema;
- Patients with severe liver dysfunction or edema caused by liver disease (cirrhosis);
- Other patients with hypothyroidism, proteinuria, and problems at the joint orankle joint
- Those who have cerebrovascular disease, unstable angina, or transient ischemic attack,or those who have had coronary artery bypass graft or coronary angioplasty;
- Patients who may develop edema by concomitant drugs at screening:
- Drugs that constrict intrarenal blood vessels (e.g. nonsteroidalanti-inflammatory drugs, cyclosporine, etc.);
- Drugs that dilate arterioles (e.g. vasodilators, etc.);
- Drugs that increase sodium reabsorption in the kidneys (e.g. steroids, etc.);
- Drugs that damage capillaries (e.g. interleukin-2, etc.);
- Glitazone-based drugs for diabetes
- Those who show hypersensitive reaction* to the investigational product;
- Those who are taking the following drugs that may cause drug interactions:
- Drugs that may change the plasma concentration of amlodipine [e.g. CYP3A4inducers (e.g. rifampicin, St. John's wort (Hypericum perforatum), etc.);
- Drugs that may increase the antihypertensive action [e.g. other antihypertensives (calcium channel blockers, beta blockers, ACEi, ARB, alpha blockers, diuretics,nitroglycerin), tricyclic antidepressants (amitriptyline, desipramine,imipramine, nortriptyline, protriptyline, trimipramine, etc.), nitrateformulation, baclofen, pioglitazone, sildenafil, etc.];
- Systemic corticosteroids (fluocinolone, triamcinolone), etc.: Local applicationallowed;
- Drugs that may increase the inhibitory action of muscle contraction [e.g.antiarrhythmics (amiodarone, quinidine, etc.);
- Drugs that may cause ventricular spasms (e.g. intravenous administration ofdantrolene and verapamil);
- Drugs that may increase the risk of hypotension [e.g. CYP3A4 inhibitors (clarithromycin), etc.]
- Patients in a state of chronic inflammation requiring chronic anti-inflammatorytreatment;
- Those who have participated in other interventional clinical studies within 6 monthsof screening;
- Those who have been diagnosed as having malignant tumors within 5 years of screening;
- Those who showed clinically significant abnormal results in electrocardiogram andlaboratory tests at screening;
- Those who are pregnant or lactating, or have been confirmed as being pregnant throughthe Urine HCG test;
- Those who have been judged to be inappropriate to participate in the clinical study bythe principal investigator or subinvestigator.
Study Design
Total Participants: 80
Study Start date:
October 28, 2020
Estimated Completion Date:
May 23, 2022
Study Description
Connect with a study center
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofActive - Recruiting
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