UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005522
Receipt No. R000002637
Scientific Title Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients.
Date of disclosure of the study information 2011/04/28
Last modified on 2011/04/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients.
Acronym Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients.
Scientific Title Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients.
Scientific Title:Acronym Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients.
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate hypotensive effects of telmisartan 40mg/d plus hyrdochlorothiazide 12.5mg/d or plus eplerenone 50mg/d or dose increase to telmisartan and metabolic syndrome who is not insufficient effect with telmisartan 40mg/d alone.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Systolic and diastolic blood pressure
Key secondary outcomes home blood pressure, serum 1ipids, FBG, HbA1c, IRI, hsCRP, adipocytokine, plasma renin activity, plasma aldosterone

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dose of telmisartan increased from 40mg/d to 80mg/d (6-month administration).
Interventions/Control_2 Hydrochlorothiazide 12.5mg/d add to telmisartan 40mg/d (6-month administration).
Interventions/Control_3 Eplerenone 50mg/d add to telmisartan 40mg/d (6-month administration).
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 1.Hypertensive patient who administrated telmisartan for three months or more, and still blood pressure is higher than Guideline target level. 2.Patient who have one or more metabolic syndorome risk factor (obesity,IGT etc.)
Key exclusion criteria 1. Pregnant or lactating women 2. Malignant hypertension and secondary hypertension 3. Diabetes mellitus patient with unstable glycemic control whose HbA1c is more than 8.0%, or complicated with diabetic nephropathy more than stage 2 4. Patient who is intoleramce or allergic aginst hydrochlorothiazide 5. FBG is more than 400mg/dL 6. patient who has kidney or liver dysfunction
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyu Takeda
Organization Kanazawa University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 13-1 takara-machi, Kanazawa, Japan
TEL 076-265-2252
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyu Takeda
Organization Kanazawa University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 13-1 takara-machi, Kanazawa, Japan
TEL 076-265-2252
Homepage URL
Email takeday@med.kanazawa-u.ac.jp

Sponsor
Institute Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department

Funding Source
Organization None
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 金沢大学附属病院(石川県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Preinitiation
Date of protocol fixation
2011 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
2013 Year 05 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 28 Day
Last modified on
2011 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002637

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.