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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01390415
• Collaborator: (none)
• Enrollment: 136
• Duration (Months): 23

Study Details

Study Description

Brief Summary

This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.

Condition or Disease	Intervention/Treatment	Phase
Hypertension

Study Design

• Study Type: Observational
• Actual Enrollment: 136 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Survey to Evaluate the Renoprotective Effect of Losartan in Type II Diabetic Patients With Microalbuminuria and Hypertension in Real Life
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Macroalbuminuria After 6 Months of Treatment [Baseline and Month 6]

   Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.

Secondary Outcome Measures

1. Systolic Blood Pressure (SBP) [Baseline and Month 6]

   SBP at baseline and month 6.

2. Diastolic Blood Pressure (DBP) [Baseline and Month 6]

   DBP at baseline and month 6.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01390415
• Other Study ID Numbers: 0954-365
• First Posted: Jul 11, 2011
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Recruitment Details	All the medical charts of the targeted study patients were reviewed. The study index period (when patients had to have received treatment for 6 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively.
Pre-assignment Detail	211 patients were enrolled in this study. Among these patients, 136 patients were eligible after excluding 75 patients.

Arm/Group Title	Losartan 50 mg	Losartan 100 mg
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	99	37
COMPLETED	99	37
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Losartan 50 mg	Losartan 100 mg	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	99	37	136
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.8 (8.1)	59.7 (6.0)	59.0 (7.5)
Sex: Female, Male (Count of Participants)
Female	39 39.4%	16 43.2%	55 40.4%
Male	60 60.6%	21 56.8%	81 59.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Macroalbuminuria After 6 Months of Treatment
Description	Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.
Time Frame	Baseline and Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Losartan 50 mg	Losartan 100 mg
Arm/Group Description	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.	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.
Measure Participants	99	37
Number [participants]	7 7.1%	6 16.2%

2. Secondary Outcome

Title	Systolic Blood Pressure (SBP)
Description	SBP at baseline and month 6.
Time Frame	Baseline and Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Losartan 50 mg	Losartan 100 mg
Arm/Group Description	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.	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.
Measure Participants	99	37
Baseline (n=85; n=36)	149.5 (16.0)	145.5 (11.1)
Month 6 (n=72; n=22)	136.9 (14.0)	138.4 (11.3)
Change from Baseline at Month 6 (n=72; n=22)	-14.0 (1.6)	-7.0 (3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan 50 mg, Losartan 100 mg
	Comments	Between-group comparison of Change from Baseline at Month 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0374
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Diastolic Blood Pressure (DBP)
Description	DBP at baseline and month 6.
Time Frame	Baseline and Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Losartan 50 mg	Losartan 100 mg
Arm/Group Description	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.	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.
Measure Participants	99	37
Baseline (n=85; n=36)	85.6 (12.4)	84.0 (8.7)
Month 6 (n=72; n=22)	78.2 (8.8)	80.1 (8.2)
Change from Baseline at Month 6 (n=72; n=22)	-9.3 (1.2)	-4.4 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan 50 mg, Losartan 100 mg
	Comments	Between-group comparison of Change from Baseline at Month 6
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0566
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Losartan 50 mg		Losartan 100 mg
Arm/Group Description	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.		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.
All Cause Mortality
	Losartan 50 mg		Losartan 100 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Losartan 50 mg		Losartan 100 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	Losartan 50 mg		Losartan 100 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.