UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001563 |
|---|---|
| Receipt number | R000001718 |
| Scientific Title | Randomized controlled trail on efficacy and safety of Losartan 50 mg/HCTZ 12.5 mg and Titrated Angiotensin Receptor Blockers (ARBs) in Patients who have Hypertension with Diabetes mellitus |
| Date of disclosure of the study information | 2008/12/10 |
| Last modified on | 2013/12/11 13:45:52 |
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Basic information
Public title
Randomized controlled trail on efficacy and safety of Losartan 50 mg/HCTZ 12.5 mg and Titrated Angiotensin Receptor Blockers (ARBs) in Patients who have Hypertension with Diabetes mellitus
Acronym
Study of clinical Impact of +osartan on Blood Pressure control in OSAKA II (SIMPL II)
Scientific Title
Randomized controlled trail on efficacy and safety of Losartan 50 mg/HCTZ 12.5 mg and Titrated Angiotensin Receptor Blockers (ARBs) in Patients who have Hypertension with Diabetes mellitus
Scientific Title:Acronym
Study of clinical Impact of +osartan on Blood Pressure control in OSAKA II (SIMPL II)
Region
| Japan |
Condition
Condition
Hypertension with diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of Losartan 50 mg/HCTZ 12.5 mg and maximum dose of ARBs to blood pressure, microalbuminuria and safety, in patients with hypertension with Diabetes mellitus who were failed anti-hypertensive therapy including ARB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Changing value of SBP in three-month period within 2 groups
Prevention of progress of diabetes nephrology in all trial period within 2 groups
Key secondary outcomes
 Microalbuminuria, hs-CRP, eGFR and BNP change in 3, 6, 12, 18 and 24-month period within 2 groups.
 Cost of antihypertensive medications.
 Composite endpoint – All cause death, AMI, unstable angina, CABG, PCI, hospitalization of CHF, Stroke, major vascular events.
 Echocardiographic evaluation (LVMI, E/A and EF), cystatin C and HOMA-R change in 12, 24-month period within 2 groups
 The safety of Losartan 50 mg/HCTZ 12.5 mg and maximum dose of ARBs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Losartan 50 mg/HCTZ 12.5 mg
Interventions/Control_2
maximum dose of ARBs
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Hypertension patients with diabetes mellitus who has previously been treated with ARB and whose blood pressure has not been adequately controlled with the treatment.
Patients has received one of five ARB monotherapyies (either Losartan 50mg, Candesartan 8mg, Valsartan 80mg, Telmisartan 40mg, or Olmesartan 20mg) at least for 3 months.
Patients has SBP less than 130mmHg, and/or DBP more than 80mmHg
Patients has HbA1c more than 5.8% (FBS more than 110mg/dl or BS more than140mg/dl) in present or past or been previously treated with diabetetic medication.
2. Patients of between 30 and 74 years of age.
3. Both gender is included.
4. In and out patients
5. Male patients with SCrless than1.5mg/dl, and female patients with SCr less than 1.2mg/dl
6. Patients with microalbuminuria data in last 6 months.
7. Patients who understands study procedures and agree to participate in the study by giving written informed consent prior to the study start.
Key exclusion criteria
1. Patients with IDDM
2. Patients with nephropathy (urinary albumin-to-creatinine ratio is more than 300mg/gCr).
3. Patients with poor controlled diabetes mellitus (HbA1c more than 10%)
4. Patients with insukin treatment
5. Patients with poor controlled hypertension (SBP more than 180mmHg or DBP more than 110mmHg)
6. Patients with malignant hypertension
7. Patients with critical liver damage. (ALT or AST is over 3 times of normal)
8. Patients with attack of gout
9. Patients has had any severe cardiovascular events with hospitalization within the 6 months prior to informed consent.
10. Patients is pregnant or breast feeding; or is a female expecting to conceive within the projected duration of the study.
11. Patients with the secondary hypertension.
12. Patients with non-diabetic nephropathy such as chronic glomerulonephritis. polycystic kidney disease. reniculus
13. Patients with heart failure
14. Patients has poor controlled arrhythmia.
15. Patients has treated with diuretics.
16. Patients has allergia of test drugs
17. Patients who are considered not to be negligible to the study by the investigator due to medical reasons.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatsugu Hori |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
President
Zip code
Address
1-3-3 Nakamichi, Higasinari-Ku Osaka
TEL
06-6972-1181
hori-ma@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatsugu Hori |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
President
Zip code
Address
Higashinari-ku Osaka
TEL
06-6972-1181
Homepage URL
hori-ma@mc.pref.osaka.jp
Sponsor or person
Institute
SIMPL OSAKA Investigators
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
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
| 2008 | Year | 12 | Month | 10 | 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
| 2008 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 10 | Day |
Last modified on
| 2013 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001718
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