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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003922
Receipt No. 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

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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
Email

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
Email ssaitoh@sapmed.ac.jp

Sponsor
Institute SPEED investigators
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004492

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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