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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000941
Receipt No. R000000699
Scientific Title Short Treatment with the Angiotensin Receptor Blocker Candesartan Surveyed by Telemedicine
Date of disclosure of the study information 2008/04/01
Last modified on 2013/12/10

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Basic information
Public title Short Treatment with the Angiotensin Receptor Blocker Candesartan Surveyed by Telemedicine
Acronym STAR CAST Study
Scientific Title Short Treatment with the Angiotensin Receptor Blocker Candesartan Surveyed by Telemedicine
Scientific Title:Acronym STAR CAST Study
Region
Japan

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

Objectives
Narrative objectives1 To examine the effects of one year treatment of untreated patients with mild hypertension with the angiotensin receptor blocker candesartan or the calcium channel blocker nifedipine slow-release, followed by tapering and discontinuation of the drug for a further year, in order to compare the withdrawal of hypertension therapy with these two agents.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Antihypertensive drug withdrawal success rates
Key secondary outcomes 1. Median duration of drug withdrawal
2. Changes in home and office BP values after drug withdrawal

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Candesartan 4-12 mg po qd
Interventions/Control_2 Nifedipine XL 10-40 mg po qd
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
59 years-old >=
Gender Male and Female
Key inclusion criteria Patients satisfying all the following criteria will be included in the study:
1.Age 30 to 59
2.Family history of hypertension (within 2 degrees)
3.Diagnosed with mild hypertension according to JSH 2004 guidelines (SBP of 140-159 mmHg and DBP of 90-99 mmHg on two separate occasions), taking no hypertensive medications for the previous 3 months.
4.Agrees to the study with informed consent.
Key exclusion criteria Patients satisfying any one of the following criteria will be excluded from the study:
1.Secondary hypertension
2.Diabetes mellitus (HbA1c values of 6.5% or greater)
3.Renal dysfunction (serum creatinine values of 2 mg/dl or greater)
4.Patients with a history of cardiovascular disease (stroke, transient ischemic attack, coronary heart disease, heart failure)
5.Patients with severe liver dysfunction
6.Patients with malignancies
7.Pregnant patients, or patients intending to be pregnant
8.Other patients judged to be inappropriate by the attending physician
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Itoh
Organization School of Medicine, Keio University
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3796
Email hiito@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Sasamura
Organization School of Medicine, Keio University
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3796
Homepage URL
Email sasamura@a8.keio.jp

Sponsor
Institute Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Japan Vascular Disease Research Foundation
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
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
2008 Year 04 Month 01 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
2007 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 12 Month 08 Day
Last modified on
2013 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000699

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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