UMIN-CTR Clinical Trial

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
Email	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
Email	hori-ma@mc.pref.osaka.jp

Sponsor
Institute	SIMPL OSAKA Investigators
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001718

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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