UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001436
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email mhori@medone.med.osaka-u.ac.jp

Sponsor
Institute SIMPL OSAKA INVESYGATORS
(Masatsugu Hori)
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.