A 52 Week Study to Evaluate the Effects of Losartan With or Without HCTZ on Plasma Glucose, Metabolic Parameters, Blood Pressure in Hypertensive Patients With Metabolic Syndrome

This study has been completed.

Study NCT00546052 Information provided by Merck

First Received on October 17, 2007. Last Updated on April 20, 2010 History of Changes

Results First Received: January 8, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Hypertension Metabolic Disorder
Intervention:	Drug: losartan potassium (+) hydrochlorothiazide

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient In: 12-Sep-2005 Last Patient In: 29-Dec-2006 Last Patient Last Visit: 31-Jan-08 Total number of Sites (General Practitioners and Family Physicians in Canada): 209

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
24 patients not included in the Intention to Treat (ITT) analysis because they did not receive study medication and had no follow up visits. Total ITT population = 1714.

Reporting Groups

	Description
Losartan +/- Hydrochlorothiazide	Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.

Participant Flow: Overall Study

	Losartan +/- Hydrochlorothiazide
STARTED	1738
Week 4	1714
Week 8	1680
Week 12	1650
Week 32	1583
Week 52	1511
COMPLETED	1511
NOT COMPLETED	227
Adverse Event	47
Lost to Follow-up	144
Protocol Violation	9
Withdrawal by Subject	20
Non Compliance	7

Baseline Characteristics

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Reporting Groups

	Description
Losartan +/- Hydrochlorothiazide	Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.

Baseline Measures

	Losartan +/- Hydrochlorothiazide
Number of Participants [units: participants]	1714
Age [units: Years] Mean ± Standard Deviation	54.93 ± 11.29
Age, Customized [units: participants]
<=45.00	326
45.01 - 52.00	359
52.01 - 58.00	356
58.01 - 65.00	346
>=65.00	326
Missing	1
Gender [units: participants]
Female	734
Male	980
Race/Ethnicity, Customized [units: participants]
Caucasian	1451
Black	32
Asian	200
Native American	11
Other	19
Missing	1
Body Mass Index [units: Kg/m2] Mean ± Standard Deviation	33.23 ± 5.59
C-Reactive Protein [units: mg/L] Mean ± Standard Deviation	5.4 ± 8.8
Diastolic Blood Pressure [units: mm Hg] Mean ± Standard Deviation	90.54 ± 8.16
Fasting Blood Glucose [units: mmol/L] Mean ± Standard Deviation	5.7 ± 0.7
Heart Rate [units: Beats per Minute (BPM)] Mean ± Standard Deviation	75 ± 8.0
Hemoglobin A1c [units: Percent] Mean ± Standard Deviation	5.71 ± 0.59
High Density Lipoprotein-C [units: mol/L] Mean ± Standard Deviation	1.23 ± 0.33
Low Density Lipoprotein-C [units: mmol/L] Mean ± Standard Deviation	3.17 ± 0.93
Systolic Blood Pressure [units: mm Hg] Mean ± Standard Deviation	148.22 ± 10.72
Total Cholesterol [units: mmol/L] Mean ± Standard Deviation	5.36 ± 1.05
Triglycerides [units: mmol/L] Mean ± Standard Deviation	2.16 ± 1.16
Uric Acid [units: mmol/L] Mean ± Standard Deviation	365.8 ± 85.4
Weight [units: Kilograms (Kg)] Mean ± Standard Deviation	92.5 ± 18.1

Outcome Measures

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1. Primary:

Change in Hemoglobin A1c Between 52 Weeks and Baseline [ Time Frame: 52 Weeks - Baseline ]

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2. Primary:

Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments [ Time Frame: 52 Weeks - Baseline ]

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3. Secondary:

Target Blood Pressure [ Time Frame: 52 Weeks ]

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4. Secondary:

Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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5. Secondary:

Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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6. Other Pre-specified:

Change in Waist Circumference Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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7. Other Pre-specified:

Change in Body Mass Index Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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8. Other Pre-specified:

Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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9. Other Pre-specified:

Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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10. Other Pre-specified:

Percent Change in Triglycerides Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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11. Other Pre-specified:

Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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12. Other Pre-specified:

Absolute Change in Uric Acid Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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13. Other Pre-specified:

Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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
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Results Point of Contact:

Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00546052 History of Changes
Other Study ID Numbers:	2007_030, MK0954A-331
Study First Received:	October 17, 2007
Results First Received:	January 8, 2009
Last Updated:	April 20, 2010
Health Authority:	Canada: Health Canada