BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00546754

First received: October 17, 2007

Last updated: April 20, 2010

Last verified: April 2010

History of Changes

Results First Received: March 26, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: losartan potassium (+) hydrochlorothiazide Drug: Comparator: Valsartan (+) 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: MAY-04-2007 Last patient out: APRIL-16-2009 Total number of sites: 163 sites in Canada

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

First patient in: MAY-04-2007

Last patient out: APRIL-16-2009

Total number of sites: 163 sites in Canada

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Participant Flow: Overall Study

	Losartan 50 mg/HCTZ 12.5 mg	Valsartan 80 mg/HCTZ 12.5 mg
STARTED	425 ^[1]	383 ^[1]
Treated	416 ^[2]	373 ^[2]
Week 6	396	347
Week 12	375	334
COMPLETED	375	334
NOT COMPLETED	50	49
Serious Adverse Event	1	1
Adverse Event	11	16
Lack of Efficacy	1	1
Lost to Follow-up	9	15
Protocol Violation	3	0
Withdrawal by Subject	6	7
Dyspnea	1	0
Per Data Query, Less Than 4 Wks Coversyl	1	0
Hip Replacement	1	0
Suicide	1	0
Missing Cooperation	1	0
Elevated Creatinine and Potassium levels	0	1
Patient's Decision	0	1
Missing	14	7

[1]	Number of patients enrolled and randomized
[2]	Patients that received at least one dose of study medication and had 1 follow-up visit

Baseline Characteristics

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Reporting Groups

	Description
Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure. 416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])
Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure. 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])
Total	Total of all reporting groups

Description

Losartan 50 mg/HCTZ 12.5 mg

Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])

Valsartan 80 mg/HCTZ 12.5 mg

Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])

Total

Total of all reporting groups

Baseline Measures

	Losartan 50 mg/HCTZ 12.5 mg	Valsartan 80 mg/HCTZ 12.5 mg	Total
Number of Participants [units: participants]	416	373	789
Age [units: years] Mean ± Standard Deviation	58.7 ± 11.11	58.3 ± 10.26	58.5 ± 10.71
Gender [units: participants]
Female	197	180	377
Male	219	193	412
Race/Ethnicity, Customized [units: participants]
Caucasian	364	326	690
Black	8	13	21
Hispanic	2	0	2
Asian	34	29	63
Native	4	4	8
East Indian	1	0	1
From Middle East	1	0	1
Unknown	2	1	3

Outcome Measures

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1. Primary:

Change in Systolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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2. Primary:

Change in Diastolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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3. Secondary:

Change in Systolic Blood Pressure From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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4. Secondary:

Change in Diastolic Blood Pressure From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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5. Secondary:

Number of Patients Achieving Target Blood Pressure at Week 6 [ Time Frame: Week 6 ]

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6. Secondary:

Number of Patients Achieving Target Blood Pressure at Week 12 [ Time Frame: 12 Weeks ]

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7. Secondary:

Time to Achieve Target Blood Pressure [ Time Frame: 12 weeks ]

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8. Secondary:

Change in Uric Acid From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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Measure Type	Secondary
Measure Title	Change in Uric Acid From Baseline to Week 6
Measure Description	No text entered.
Time Frame	Baseline and Week 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 298 and 269 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively

Reporting Groups

	Description
Losartan 50 mg/HCTZ 12.5 mg	Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
Valsartan 80 mg/HCTZ 12.5 mg	Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.

Measured Values

	Losartan 50 mg/HCTZ 12.5 mg	Valsartan 80 mg/HCTZ 12.5 mg
Number of Participants Analyzed [units: participants]	298	269
Change in Uric Acid From Baseline to Week 6 [units: umol/L] Mean ± Standard Deviation	0.3 ± 53.12	21.7 ± 55.09

Statistical Analysis 1 for Change in Uric Acid From Baseline to Week 6

Groups ^[1]	All groups
Method ^[2]	ANOVA
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

9. Secondary:

Change in Uric Acid From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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10. Secondary:

Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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11. Secondary:

Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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12. Secondary:

Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]

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13. Secondary:

Change in Gamma-Glutamyl Transpeptidase (Gamma–GT) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

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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
No text entered.

Results Point of Contact:

Name/Title: Executive 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:	NCT00546754 History of Changes
Other Study ID Numbers:	2007_031, MK0954A-333
Study First Received:	October 17, 2007
Results First Received:	March 26, 2010
Last Updated:	April 20, 2010
Health Authority:	Canada: Health Canada

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