UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Termisartan or Losartan in Hypertensive Diabetic Patients with Macroalbumiuria
Title of the study (Brief title)	MOLOYAMA Study
Region	Japan

Condition
Condition	Hypertensive Diabetic Nephropathy Patients with Macroalbumiuria
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of telmisartan and losartan in hypertensive diabetic patients with macroalbumiuria
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Changes of urinary excretion of protein after 12 weeks of treatment
Key secondary outcomes	1) Changes in office blood pressure after 12 weeks treatment 2) Changes in serum creatinine,high molecular adeponectine, potassium, total cholestero, HDL-cholesterol, triglyceride, blood glucose, IRI, HbA1c, HOMA-IR after 12 weeks of treatment

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
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	Continue oral administration of Losartan (25-100mg/day)
Interventions/Control_2	Switch to oral administration of Telmisartan (20-80mg/day)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Diabetic nephropathy patients with macroalbumiuria (Urinary Protein >1+) 2)Hypertensive patients taking Losartan
Key exclusion criteria	1) Non diabetic nephropathy (e.g. IgA nephropathy, Nephrosclerosis, etc) 2) Patients who are taking ACRs and/or ARBs other than Losartan 3) Serum creatinine > 3.0mg/dl 4) Severe hypertension (Diastolic blood pressure > 120mmHg) 5) Patients who are inadequate to entry this study by physicians in charge
Target sample size	100

Research contact person
Name of lead principal investigator	Hidetomo Nakamoto
Organization	Saitama Medical University
Division name	Department of General Medicine
Address	38Morohongo, Moriyamamachi, Iruma-gun, Saitama 350-0451, Japan
TEL	049-276-1611
Email	nakamo_h@saitama-med.ac.jp

Public contact
Name of contact person	Hidetomo Nakamoto
Organization	Saitama Medical University
Division name	Department of General Medicine
Address	38Morohongo, Moroyamamachi, Iruma-gun, Saitama 350-0451, Japan
TEL	049-276-1611
Homepage URL
Email	nakamo_h@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	2007 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 03 Month 01 Day
Anticipated trial start date	2007 Year 08 Month 01 Day
Last follow-up date	2008 Year 05 Month 01 Day
Date of closure to data entry	2008 Year 06 Month 01 Day
Date trial data considered complete	2008 Year 08 Month 01 Day
Date analysis concluded	2008 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2007 Year 08 Month 09 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000954