UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003922 |
|---|---|
| Receipt number | R000004492 |
| Scientific Title | SAPPORO study to Prove the Effects of telmisartan and valsartan on Early morning blood pressure based on amlodipine treatment |
| Date of disclosure of the study information | 2010/07/20 |
| Last modified on | 2014/08/18 08:36:39 |
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Basic information
Public title
SAPPORO study to Prove the Effects of telmisartan and valsartan on Early morning blood pressure based on amlodipine treatment
Acronym
SPEED study
Scientific Title
SAPPORO study to Prove the Effects of telmisartan and valsartan on Early morning blood pressure based on amlodipine treatment
Scientific Title:Acronym
SPEED study
Region
| Japan |
Condition
Condition
patients with essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the combination therapy of the Ca channel blocker and ARB (telmisartan or valsartan) in patients with essential hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
primary outcome: home blood pressure in the early morning
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
amlodipine and telmisartan
Interventions/Control_2
amlodipine and valsartan
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
outcome patients treated with amlodipine 5 mg/day
home BP >135/85 mmHg in the early morning
Key exclusion criteria
allergy with ARB or amlodipine
pregnancy
severe liver dysfunction
severe kidney dysfunction
taking another antihypertensive agents
patients who are not recomended Ca channel blocker as the first choice
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuji Miura |
Organization
Sapporo Medical University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
S1W16 Chuo-ku Sapporo 060-8543, Japan
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Saitoh |
Organization
Sapporo Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
ssaitoh@sapmed.ac.jp
Sponsor or person
Institute
SPEED investigators
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
| 2010 | Year | 07 | Month | 20 | 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
| 2010 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 17 | Day |
Last modified on
| 2014 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004492
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
