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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004491
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Nishi-Mikawa SG-ARB association
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005313

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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