A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT01390415

First received: July 7, 2011

Last updated: August 9, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 7, 2011
Last Updated Date	August 9, 2011
Start Date ^ICMJE	September 2008
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 9, 2011)	Number of Participants With Macroalbuminuria After 6 Months of Treatment [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ] Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.
Original Primary Outcome Measures ^ICMJE (submitted: July 7, 2011)	Number of participants with macroalbuminuria >300 mg/g and ≥30% increase in macroalbuminuria [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01390415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 9, 2011)	Systolic Blood Pressure (SBP) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ] SBP at baseline and month 6. Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ] DBP at baseline and month 6.
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)
Official Title ^ICMJE	A Retrospective Survey to Evaluate the Renoprotective Effect of Losartan in Type II Diabetic Patients With Microalbuminuria and Hypertension in Real Life
Brief Summary	This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Adult participants with diabetes mellitus and hypertension treated with losartan 50 mg or 100 mg for at least 6 months in a hospital setting in Taiwan
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Losartan 50 mg Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. Losartan 100 mg Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	136
Completion Date	August 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diabetes mellitus Hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months Microalbuminuria (defined as microalbuminuria > 30 mg/g and < 300 mg/g by spot urine test) Serum creatinine ≤1.5 mg/dL for men and ≤1.4mg/dL for women Urinalysis with white blood cells (WBC) <5 cells per high power field Results of hemoglobin A1c (HbA1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available Medical history and co-morbidities (if available) listed in medical records Prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available Exclusion criteria: Treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB) before initiated treatment with losartan 50 mg or losartan 100 mg Enrollment in another clinical trial
Gender	Both
Ages	20 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01390415
Other Study ID Numbers ^ICMJE	MK-0954-365
Has Data Monitoring Committee	No
Responsible Party	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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