UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004491 |
|---|---|
| Receipt number | R000005313 |
| Scientific Title | Comparison of monotherapy with irbesartan and telmisartan for treatment of essential hypertensive patients - interventional, parallel group study using home Blood Pressure monitoring - |
| Date of disclosure of the study information | 2010/11/15 |
| Last modified on | 2011/06/23 09:20:29 |
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Basic information
Public title
Comparison of monotherapy with irbesartan and telmisartan for treatment of essential hypertensive patients - interventional, parallel group study using home Blood Pressure monitoring -
Acronym
Comparison of monotherapy with irbesartan and telmisartan for treatment of essential hypertensive patients
Scientific Title
Comparison of monotherapy with irbesartan and telmisartan for treatment of essential hypertensive patients - interventional, parallel group study using home Blood Pressure monitoring -
Scientific Title:Acronym
Comparison of monotherapy with irbesartan and telmisartan for treatment of essential hypertensive patients
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of monotherapies with irbesartan and telmisartan on home blood pressure, percents of achieving blood pressure targets, lipid and glucose profile
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the changes from baseline in home Systolic Blood Pressure between 12 week treatments of irbesartan and telmisartan
Key secondary outcomes
1.To compare the percents of achieving blood pressure targets in home Blood Pressure monitoring between 12 week treatments of irbesartan and telmisartan
2.To compare the changes from baseline in office blood pressure, home diastolic Blood Pressure, heart rates between 12 week treatments of irbesartan and telmisartan
3.To compare the changes from baseline in LDL-C, HDL-C, TG, FFA, FBS, HbA1C, UACR between 12 week treatments of irbesartan and telmisartan
4.To compare the changes from baseline in blood and urine examinations between 12 week treatments of irbesartan and telmisartan
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment of irbesartan 50-200mg/day
Interventions/Control_2
Treatment of telmisartan 20-80mg/day
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Essential hypertensive outpatients who are without antihypertensive drug at least 4 weeks prior to randomization or without a historiy of anti-hypertensive drug
2) Office SBP >=140mmHg or DBP >=90
3) Age >=30 years
4) Subjects who gave written informed consent
Key exclusion criteria
1) Allergy against irbesartan/telmisartan
2) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments
3) Impaired renal function (Cre>=2.0mg/dL)
4) Biliary obstructive disorders or level of alanine aminotransferase >= 100IU
5) Symptomatic (NYHA II, III or IV) congestive heart failure
6) Poor-controlled hypertension (SBP>=180, or DBP>=110 mmHg in office BP)
7) Severe arrythmia
8) Diabetes treated with thiazolidine
9) Malignancies or other diseases with poor prognosis
10) Pregnant
11) Subjects whose doctor in charge do not agree to join the trial
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ishihara |
Organization
Ishihara medical clinic
Division name
Head
Zip code
Address
Kamodacho-aza-minamikomba 79-1, Okazaki-City, Aichi, 444-2121 Japan
TEL
0564-22-2167
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ishihara |
Organization
Nishi-Mikawa SG-ARB association
Division name
Ishihara medical clinic
Zip code
Address
TEL
0564-22-2167
Homepage URL
Sponsor or person
Institute
Nishi-Mikawa SG-ARB association
Institute
Department
Personal name
Funding Source
Organization
Ishihara medical Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
石原クリニック（愛知県），トヨタ記念病院循環器科（愛知県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 01 | Day |
Last modified on
| 2011 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005313
