SAALT: Subtracting Salt and Adding Losartan Trial (0954-335)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00739674

First received: August 20, 2008

Last updated: November 4, 2010

Last verified: November 2010

History of Changes

Results First Received: July 14, 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 [HCTZ] + calcium channel blocker [CCB]) Behavioral: Low Salt Diet

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: FEB-05-2008 Last patient out: JAN-15-2010 Total number of sites: 109 sites in Canada

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Losartan-Based Regimen Alone (L Group)	Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including hydrochlorothiazide (HCTZ) 12.5 mg or 25 mg and calcium channel blocker (CCB) as needed to achieve target blood pressure.
Diet Management and Losartan-Based Regimen (DML Group)	Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt Dietary Approaches to Stop Hypertension (DASH) diet management.

Participant Flow: Overall Study

	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
STARTED	535	457
Screening Failures	19	17 ^[1]
Site 212 Removal	19 ^[2]	13 ^[2]
No Follow-up Data	33	18
Dietician Consultation >30 Days	1 ^[3]	9 ^[3]
Intent-to-treat (ITT) Population	463 ^[1]	400 ^[1]
COMPLETED	354	335
NOT COMPLETED	181	122
Screening failures	19	17
Site 212 removal	19	13
No follow-up data	33	18
Dietician consultation >30 days	1	9
Adverse Event	22	13
Death	1	0
Lack of Efficacy	1	0
Lost to Follow-up	52	30
Protocol Violation	5	5
Withdrawal by Subject	9	9
Reason missing	2	0
Clinic closed	6	4
Patient moved	3	2
Non compliant	4	0
Unable to attend visit	3	1
Home monitoring off meds	1	0
Erectile dysfunction	0	1

[1]	ITT population took at least one dose of the study medication and had one follow-up visit.
[2]	lack of source documentation & frequent discrepancies between source notes and case report entries.
[3]	Patients with dietician consultations >30 days after visit 1 were not included in the data analysis.

Baseline Characteristics

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Reporting Groups

	Description
Losartan-Based Regimen Alone (L Group)	Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure. The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit).
Diet Management and Losartan-Based Regimen (DML Group)	Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management. The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit).
Total	Total of all reporting groups

Description

Losartan-Based Regimen Alone (L Group)

Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.

The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit).

Diet Management and Losartan-Based Regimen (DML Group)

Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.

The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit).

Total

Total of all reporting groups

Baseline Measures

	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)	Total
Number of Participants [units: participants]	463	400	863
Age [units: years] Mean ± Standard Deviation	56.05 ± 11.54	54.59 ± 11.98	55.38 ± 11.76
Gender [units: participants]
Female	239	208	447
Male	224	192	416
Race/Ethnicity, Customized [units: participants]
White	404	369	773
Black	9	4	13
Hispanic	2	1	3
Asian	38	20	58
Native Indian	3	2	5
Other	7	4	11
Cardiovascular Risk ^[1] [units: Participants]
High	112	92	204
Medium	94	61	155
Low	218	216	434
Not Available	35	27	62
Missing	4	4	8
Diastolic Blood Pressure [units: mm Hg] Mean ± Standard Deviation	90.67 ± 9.19	91.43 ± 9.98	91.02 ± 9.57
Systolic Blood Pressure [units: mm Hg] Mean ± Standard Deviation	151.23 ± 10.80	151.11 ± 12.55	151.17 ± 11.64
Weight [units: Kilograms] Mean ± Standard Deviation	85.41 ± 19.95	89.17 ± 20.18	87.16 ± 20.13

[1]	Cardiovascular Risk according to Framingham Equation

Outcome Measures

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1. Primary:

Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline [ Time Frame: 14 Weeks ]

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2. Primary:

Change in Systolic Blood Pressure From Baseline to Week 14 [ Time Frame: 14 Weeks ]

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3. Primary:

Change in Diastolic Blood Pressure From Baseline to Week 14 [ Time Frame: 14 Weeks ]

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4. Secondary:

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

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5. Secondary:

Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline [ Time Frame: 10 Weeks ]

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6. Secondary:

Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline [ Time Frame: 40 Weeks ]

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

Change in Systolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ]

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10. Secondary:

Change in Diastolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ]

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11. Secondary:

Time to Achieve the Target Blood Pressure From Baseline [ Time Frame: 14 Weeks ]

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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: 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:	NCT00739674 History of Changes
Other Study ID Numbers:	MK0954A-335, 2008_022
Study First Received:	August 20, 2008
Results First Received:	July 14, 2010
Last Updated:	November 4, 2010
Health Authority:	Canada: Health Canada

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