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

Results First Received: August 9, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Retrospective
Condition:	Hypertension

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
211 patients were enrolled in this study. Among these patients, 136 patients were eligible after excluding 75 patients.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Losartan 50 mg	Losartan 100 mg
STARTED	99	37
COMPLETED	99	37
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Losartan 50 mg	Losartan 100 mg	Total
Number of Participants [units: participants]	99	37	136
Age [units: years] Mean ± Standard Deviation	58.8 ± 8.1	59.7 ± 6.0	59.0 ± 7.5
Gender [units: participants]
Female	39	16	55
Male	60	21	81

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants With Macroalbuminuria After 6 Months of Treatment [ Time Frame: Baseline and Month 6 ]

Show Outcome Measure 1

2. Secondary:

Systolic Blood Pressure (SBP) [ Time Frame: Baseline and Month 6 ]

Show Outcome Measure 2

3. Secondary:

Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and Month 6 ]

Show Outcome Measure 3

Serious Adverse Events

Hide Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
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.

Serious Adverse Events

	Losartan 50 mg	Losartan 100 mg
Total, serious adverse events
# participants affected / at risk	0/99 (0.00%)	0/37 (0.00%)

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01390415 History of Changes
Other Study ID Numbers:	MK-0954-365
Study First Received:	July 7, 2011
Results First Received:	August 9, 2011
Last Updated:	August 9, 2011
Health Authority:	Taiwan: Institutional Review Board

To Top