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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007682
Receipt No. R000009061
Scientific Title Effect of Switching from Telmisartan, Valsartan, Olmesartan or Losartan to Candesartan on Morning Hypertension
Date of disclosure of the study information 2012/04/07
Last modified on 2012/04/06

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Basic information
Public title Effect of Switching from Telmisartan, Valsartan, Olmesartan or Losartan to Candesartan on Morning Hypertension
Acronym Effect of Switching from Telmisartan, Valsartan, Olmesartan or Losartan to Candesartan on Morning Hypertension
Scientific Title Effect of Switching from Telmisartan, Valsartan, Olmesartan or Losartan to Candesartan on Morning Hypertension
Scientific Title:Acronym Effect of Switching from Telmisartan, Valsartan, Olmesartan or Losartan to Candesartan on Morning Hypertension
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of candesartan on morning hypertension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the achievement rate of target BPs (≤ 135/85 mmHg in the morning and ≤ 140/90 mmHg at office)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 antihypertensives
Interventions/Control_2
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) aged 20 to 70 years old; 2) hypertensive patients without adequately controlled (&#8805; 135/85 mmHg in the morning); and 3) treated with the standard doses of ARBs except candesartan (losartan 50 mg, valsartan 80 mg, telmisartan 40 mg, or olmesartan 20 mg)
Key exclusion criteria 1) severe hypertension (&#8805; 180/110 mmHg); 2) malignant disease; 3) serious renal dysfunction (serum creatinine &#8805; 2.0 mg/dL); and 4) secondary hypertension
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Takano
Organization Chiba University Graduate School of Medicine
Division name Chiba University Graduate School of Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Science and Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Science and Medicine
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

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 07 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 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
2012 Year 04 Month 06 Day
Last modified on
2012 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009061

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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