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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001563 |
Receipt No. | 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 |
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) | |
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Condition | ||||
Condition | Hypertension with diabetes mellitus | |||
Classification by specialty |
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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 |
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Interventions/Control_1 | Losartan 50 mg/HCTZ 12.5 mg | |
Interventions/Control_2 | maximum dose of ARBs | |
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Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
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Interventions/Control_9 | ||
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Eligibility | ||||
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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. |
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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. |
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Target sample size | 300 |
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Name of lead principal investigator |
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Organization | Osaka Medical Center for Cancer and Cardiovascular Diseases
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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 |
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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 | |
Institute | SIMPL OSAKA Investigators |
Institute | |
Department |
Funding Source | |
Organization | Japan Heart Foundation |
Organization | |
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Category of Funding Organization | Non profit foundation |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
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Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
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