UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Antihypertensive effect of combination therapy of telmisartan and low dose hydrochrolthiazide in hypertemnsive patients
Title of the study (Brief title)	FUJIYAMA Study 2
Region	Japan

Condition
Condition	Severe hypertensive patients with uncontrolled hypertension
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the antihypertensive effect of telmisartan and low-dose hydrochrolthiazide in patients with severe hypertension
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Changes of morning and evening home blood pressure
Key secondary outcomes	Changes in office blood pressure, uric acid, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, fast blood glucose and HbA1c

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continuous oral administration of amlodipine (5-7.5mg/day)
Interventions/Control_2	Switch to oral administration of telmisartan (40-80mg/day)+low-dose hydrochrolthiazide (12.5mg/day) combination therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hypertensive patients (office systolic blood pressure over 140 mmHg and/or office diastolic blood pressure over 90 mmHg) with oral administration of amlodipine (5mg/day)
Key exclusion 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
Target sample size	60

Research contact person
Name of lead principal investigator	Hidetomo Nakamoto
Organization	Saitama Medical University
Division name	Department of General Medicine
Address	38Morohongo, Moroyamamachi, Iruma-gun, Saitama350-0451, Japan
TEL	049-276-1611
Email	nakamo_h@saitama-med.ac.jp

Public contact
Name of contact person	Hidetomo Nakamoto
Organization	Saitama Medical University
Division name	Department of General Medicine
Address	38Morohongo, Moroyamamachi, Iruma-gun, Saitama350-0451, Japan
TEL	049-276-1611
Homepage URL
Email	nakamo_h@saitama-med.ac.jp

Sponsor
Institute	Non profit Organization LINE
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Non profit Organization LINE
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2007 Year 08 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 03 Month 01 Day
Anticipated trial start date	2007 Year 08 Month 01 Day
Last follow-up date	2008 Year 03 Month 01 Day
Date of closure to data entry	2008 Year 06 Month 01 Day
Date trial data considered complete	2008 Year 07 Month 01 Day
Date analysis concluded	2008 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2007 Year 08 Month 09 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000956