Comparison of the efficacy and safety of cilnidipine 10mg/valsartan 160mg combination therapy, cilnidipine 5mg/valsartan 160mg combination therapy and valsartan 160mg monotherapy in hypertensive patients inadequately controlled with valsartan 160mg monotherapy

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0001947
• Lead Sponsor: Ildong pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

1) 20 years old or more adult Men and Ladies
2) who meet the following criteria to patients diagnosed with essential hypertension
- If screening before treated with anti-hypertensive drug
- In the case of naïve patients (patients without a history of antihypertensive drug administration for more than 30 days) sit Diastoloc Blood Pressure = 95mmHg screening point
3) valsartan 160mg monotherapy (run-in period) 4 weeks patients (110mmHg> sit Diastoloc Blood Pressure = 90mmHg seems insufficient reaction)
4) sufficient understanding of the agreement and the parties agree in writing

Exclusion Criteria

1) screening blood pressure measurement of blood pressure difference between each measured three times the average of three blood pressure measurements after eight loci with high DBP(Diastolic Blood Pressure) - both arms over each sit SBP(Systolic blood pressure) 20mmHg or sit DBP(Diastolic Blood Pressure) 10mmHg or more patients
(* DBP(Diastolic Blood Pressure) SBP(Systolic blood pressure) is to select the high-arm when the same. If the same DBP(Diastolic Blood Pressure) and SBP(Systolic blood pressure), and select the right arm)
2) the average time patients randomized in a sit SBP(Systolic blood pressure)=180mmHg
3) patients with a history of hypersensitivity reactions to drugs based on Dihydropyridine
4) Patients with a history of hypersensitivity to the drug in the angiotensin II receptor blocker system
5) Patients with secondary hypertension or secondary hypertension is suspected (aortic coarctation, and primary aldosteronism, renal artery stenosis, Cushing's disease, polycystic kidney disease, renal hypertension, pheochromocytoma, etc.)
6) Patients expect other antihypertensive drugs outside of clinical medicine during the test period (ACE(Angiotensin-Converting enzyme) inhibitor, ß-blockers, calcium antagonists, angiotensin II receptor blocker, diuretics, a-blockers, vasodilators, etc.)
7) The second type does not type 1 diabetes patients and control patients with diabetes (HbA1c=9 If)
8)- Severe heart disease {heart failure (NYHA(New york Heart Association) class III and IV)},
- A person who is newly diagnosed disease for the last 6 months down,: ischemic heart disease (angina pectoris and myocardial infarction), peripheral vascular disease
- Recently I received treatment within 6 months following the corresponding character: percutaneous transluminal coronary angioplasty, coronary artery bypass grafting (CABG)
9) severe atrial fibrillation, atrial flutter, or the party who has the serious arrhythmia with ventricular tachycardia
10) Severe cerebrovascular disorders (stroke within 6 months etc.)
11) Now with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, clinically meaningful aortic or mitral stenosis on
12) Now with a history of shock, fainting, consciousness disorders of the blood pressure
13) hyperkalemia patient, or sodium patient body fluid shortage
14) Patients with known moderate or malignant retinopathy
15) or hereditary angioedema, ACE(Angiotensin-Converting enzyme) inhibitor or ARB(Angiotensin II Receptor Blocker) therapy when the party with a history of angioedema
16) patients with severe liver failure, liver cirrhosis or biliary obstruction, cholestasis patients
17) Clinically significant hematologic findings seen more than 2mg / dl kidney disease (serum creatinine levels or hemodialysis patients) or liver (ALT or AST more than 2 times the upper limit of normal) patients
18) If a surgical or medical conditions which can significantly change the absorption, distribution, metabolism and excretion of a drug which is either of the following (but not limited to): gastrectomy, upper small intestine anastomosis (gastro-enterostomy ) or intestinal resection (bowel resection), bypass the gastrointestinal tract, gastrointestinal stapled (stapling), or gastrointestinal banding (banding) major gastrointestinal surgical history, history of active inflammatory bowel syndrome within the previous 12 months of the current or the like. Currently there are active gastritis, ulc

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The combination of the two treated groups the mean reduction in sitDBP (Cilnidipine 10mg / Valsartan 160mg, Cilnidipine 5mg / Valsartan 160mg) alone will be superior if compared to the valsartan 160mg group.