UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000798 |
|---|---|
| Receipt number | R000000956 |
| Scientific Title | Antihypertensive effect of combination therapy of telmisartan and low dose hydrochrolthiazide in hypertemnsive patients |
| Date of disclosure of the study information | 2007/08/15 |
| Last modified on | 2016/04/27 21:26:18 |
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Basic information
Public title
Antihypertensive effect of combination therapy of telmisartan and low dose hydrochrolthiazide in hypertemnsive patients
Acronym
FUJIYAMA Study 2
Scientific Title
Antihypertensive effect of combination therapy of telmisartan and low dose hydrochrolthiazide in hypertemnsive patients
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical University
Division name
Department of General Medicine
Zip code
Address
38Morohongo, Moroyamamachi, Iruma-gun, Saitama350-0451, Japan
TEL
049-276-1611
nakamo_h@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical University
Division name
Department of General Medicine
Zip code
Address
38Morohongo, Moroyamamachi, Iruma-gun, Saitama350-0451, Japan
TEL
049-276-1611
Homepage URL
nakamo_h@saitama-med.ac.jp
Sponsor or person
Institute
Non profit Organization LINE
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000956
