UMIN ID: UMIN000000798
Registered date:15/08/2007
Antihypertensive effect of combination therapy of telmisartan and low dose hydrochrolthiazide in hypertemnsive patients
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Severe hypertensive patients with uncontrolled hypertension |
Date of first enrollment | 2007/08/01 |
Target sample size | 60 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Continuous oral administration of amlodipine (5-7.5mg/day) Switch to oral administration of telmisartan (40-80mg/day)+low-dose hydrochrolthiazide (12.5mg/day) combination therapy |
Outcome(s)
Primary Outcome | Changes of morning and evening home blood pressure |
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Secondary Outcome | Changes in office blood pressure, uric acid, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, fast blood glucose and HbA1c |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) Endocrine hypertension 2) Severe hypertension with office systolic blood pressure over 180mmHg and/or diastolic blood pressure over 90mmHg 3) Malignant hypertension 4) Continuous ventricular tachycardia or severe arrythmia (AV block II-III, Af etc) 5) Severe heart failure (NYHA III-IV) 6) Myocardial Infarction, Coronary bypass surgery, and Intervention therapy were performed within 6 months 7) Patients with exclusion criteria of amlodipine, telmisartan and hedrochrolthiazide 8) Serum creatinine >2.1mg/dl 9) Serum potassium >5.5mEq/l or <3.5mEq/l 10) Untreated hyperuricemia or treated hyperuricemia with UA>8.0mg/dl 11) ACEI, ARB and Diuretic treated patients 12) Uncontrolled diabetic patients (HbA1c>9.0%) and diabetic patients with insulin injection 13) Hypoglycemia 14) Hypersensitivity with telmisartan and hydrochrolthiazide 15) Patients who are inadequate to entry this study by physicians in charge |
Related Information
Primary Sponsor | Non profit Organization LINE |
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Secondary Sponsor | |
Source(s) of Monetary Support | Non profit Organization LINE |
Secondary ID(s) |
Contact
public contact | |
Name | Hidetomo Nakamoto |
Address | 38Morohongo, Moroyamamachi, Iruma-gun, Saitama350-0451, Japan Japan |
Telephone | 049-276-1611 |
nakamo_h@saitama-med.ac.jp | |
Affiliation | Saitama Medical University Department of General Medicine |
scientific contact | |
Name | Hidetomo Nakamoto |
Address | 38Morohongo, Moroyamamachi, Iruma-gun, Saitama350-0451, Japan Japan |
Telephone | 049-276-1611 |
nakamo_h@saitama-med.ac.jp | |
Affiliation | Saitama Medical University Department of General Medicine |