UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000941 |
|---|---|
| Receipt number | 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 08:02:30 |
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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
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
sasamura@a8.keio.jp
Sponsor or person
Institute
Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
