UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001436 |
|---|---|
| Receipt number | R000001211 |
| 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 | 2008/10/20 |
| Last modified on | 2010/04/18 10:09:20 |
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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
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
SIMPL II
Region
| Japan |
Condition
Condition
Hypertension with Diabetes mellitus
Classification by specialty
| Medicine in general | 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
Trial characteristics_2
Developmental phase
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 50mg+HCT 12.5mg
Interventions/Control_2
Losartan 100mg
or Candesartan 12mg
or Valsartan 160mg
or Telmisartan 80mg
or Olmesartan 40mg
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) Hypertensive 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 the five ARB monotherapy (either Losartan 50mg, Candesartan 8mg, Valsartan 80mg, Telmisartan 40mg, Olmesartan 20mg) at least 3 months.
- Patients has SBP>130mmHg and/or DBP 80mmHg.
- Patients has HbA1c>5.8%, or FBS>110mg/dL, or BS>140mg/dL.
2) Patients withage 30to 74 years old.
3) Both gender is included.
4) In and out patients.
5) Male patients with SCr<1.5mg/dL and Female patients with SCr<1.2mg/dL.
6) Patientsb with microalbuminuria in the last 6 months.
7) Patients who understands study prodcedures and agrees to participate in the study by giving written informed concent prior to the study start.
Key exclusion criteria
- Patients with IDDM
- Patients with nephropathy(UACR>300mg/dL).
- Patients with HbA1c>10%.
- Patients with insulin treatment.
- Patients with poor controlled hypertension (SBP>180mmHg and DBP>110mmHg)
- Patients with a critical liver disease (ALT or AST is over 3 times of normal values).
- Patients with gout.
- Patients with any severe cardiovascular events with hospitalization within the 6 months proior to informed concent.
- Patients is pregnant or brest feeding or is a femele expecting conceive within the projected duration of the study.
- Patients with secondary hypertension.
- Patients with non-diabetic renaldisaeses such as glomerulonaphritis or polycystic kidney eta.
- Patients with heart failure (above NYHA III)
- Patients with poor controlled arythmia.
- Patients treated with diuretics.
- Patients has allagy against therapy drugs.
- Patients who are considered to be not eligible to thye study by the investigator due to medical reason.
-
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatsugu Hori |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-2 Yamadaoka, Suita
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate Scholl of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
TEL
06-6879-3631
Homepage URL
mhori@medone.med.osaka-u.ac.jp
Sponsor or person
Institute
SIMPL OSAKA INVESYGATORS
(Masatsugu Hori)
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 | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
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 | 03 | 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
| 2008 | Year | 10 | Month | 17 | Day |
Last modified on
| 2010 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001211
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