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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00739674
First received: August 20, 2008
Last updated: October 9, 2015
Last verified: October 2015
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
No text entered.

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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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.
No text entered.

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 
Overall Participants Analyzed 
[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 
[1] Cardiovascular Risk according to Framingham Equation
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) 


  Outcome Measures
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1.  Primary:   Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline   [ Time Frame: 14 Weeks ]

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00739674     History of Changes
Other Study ID Numbers: 0954A-335
2008_022
MK0954A-335
Study First Received: August 20, 2008
Results First Received: July 14, 2010
Last Updated: October 9, 2015
Health Authority: Canada: Health Canada