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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00739674
• Collaborator: (none)
• Enrollment: 992
• Arms: 2
• Actual Duration (Months): 23

Study Details

Study Description

Brief Summary

To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]); Behavioral: Low Salt Diet	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 992 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Open-label Trial to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives.
• Actual Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Losartan-Based Regimen Alone (L Group) Losartan-based regimen, with sequential titration including HCTZ and CCB as needed to achieve target blood pressure.	Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]); Losartan 50 mg or 100 mg once daily for 40 weeks with sequential titration including HCTZ 12.5 mg or 25 mg and CCB only as needed to achieve target blood pressure, as follows: Patients with mild-moderate hypertension, uncontrolled hypertension on monotherapy, or diabetes: Losartan 50 mg Losartan 100 mg Losartan 100 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 25 mg Losartan 100 mg/HCTZ 25 mg + CCB Patients with severe hypertension: Losartan 50 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 25 mg Losartan 100 mg/HCTZ 25 mg + CCB Losartan 100 mg/HCTZ 25 mg + increasing CCB
Experimental: Diet Management and Losartan-Based Regimen (DML Group) Losartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet.	Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]); Losartan 50 mg or 100 mg once daily for 40 weeks with sequential titration including HCTZ 12.5 mg or 25 mg and CCB only as needed to achieve target blood pressure, as follows: Patients with mild-moderate hypertension, uncontrolled hypertension on monotherapy, or diabetes: Losartan 50 mg Losartan 100 mg Losartan 100 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 25 mg Losartan 100 mg/HCTZ 25 mg + CCB Patients with severe hypertension: Losartan 50 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 25 mg Losartan 100 mg/HCTZ 25 mg + CCB Losartan 100 mg/HCTZ 25 mg + increasing CCB; Behavioral: Low Salt Diet; Low-salt intake diet (Dietary Approaches to Stop Hypertension [DASH]) including: Healthy diet Reduction in sodium intake to less than 2300 mmol/day Low alcohol consumption (less than 2 standard drinks/day)

Outcome Measures

Primary Outcome Measures

1. Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline [14 Weeks]

   Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment

2. Change in Systolic Blood Pressure From Baseline to Week 14 [14 Weeks]

3. Change in Diastolic Blood Pressure From Baseline to Week 14 [14 Weeks]

Secondary Outcome Measures

1. Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline [6 Weeks]

   Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment

2. Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline [10 Weeks]

   Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment

3. Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline [40 Weeks]

   Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment

4. Change in Systolic Blood Pressure From Baseline to Week 6 [6 Weeks]

5. Change in Diastolic Blood Pressure From Baseline to Week 6 [6 Weeks]

6. Change in Systolic Blood Pressure From Baseline to Week 10 [10 Weeks]

7. Change in Diastolic Blood Pressure From Baseline to Week 10 [10 Weeks]

8. Time to Achieve the Target Blood Pressure From Baseline [14 Weeks]

   Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure > 161; < 221; 140/90 mm Hg But < 180/110 mm Hg)

• Non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure > 180/110 mm Hg but < 200/120 mm Hg); Patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. Patients in an urgency/emergency state are to be excluded

• Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (blood pressure > 161;< 221; 130/80 mm Hg But < 160/100 mm Hg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: blood pressure > 161;< 221; 140/90 mm Hg But < 160/100 mm Hg Or For Diabetic And/Or Coronary Artery Disease Patients: blood pressure > 161;< 221; 130/80 mm Hg But > 161;< 221; 150/90 mm Hg

• The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug

Exclusion Criteria:

• Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy. Patient With Symptomatic Heart Failure (Classes 3 And 4). Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months

• Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina

• Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Ìmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L

• Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00739674
• Other Study ID Numbers: 0954A-335; 2008_022; MK0954A-335
• First Posted: Aug 22, 2008
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hypertension; Losartan; Hydrochlorothiazide; Calcium Channel Blockers; Calcium

Study Results

Participant Flow

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

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	535	457
Screening Failures	19	17
Site 212 Removal	19	13
No Follow-up Data	33	18
Dietician Consultation >30 Days	1	9
Intent-to-treat (ITT) Population	463	400
COMPLETED	354	335
NOT COMPLETED	181	122

Baseline Characteristics

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)	Total
Arm/Group Description	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).	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 of all reporting groups
Overall Participants	463	400	863
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.05 (11.54)	54.59 (11.98)	55.38 (11.76)
Sex: Female, Male (Count of Participants)
Female	239 51.6%	208 52%	447 51.8%
Male	224 48.4%	192 48%	416 48.2%
Race/Ethnicity, Customized (participants) [Number]
White	404 87.3%	369 92.3%	773 89.6%
Black	9 1.9%	4 1%	13 1.5%
Hispanic	2 0.4%	1 0.3%	3 0.3%
Asian	38 8.2%	20 5%	58 6.7%
Native Indian	3 0.6%	2 0.5%	5 0.6%
Other	7 1.5%	4 1%	11 1.3%
Cardiovascular Risk (Number) [Number]
High	112 24.2%	92 23%	204 23.6%
Medium	94 20.3%	61 15.3%	155 18%
Low	218 47.1%	216 54%	434 50.3%
Not Available	35 7.6%	27 6.8%	62 7.2%
Missing	4 0.9%	4 1%	8 0.9%
Diastolic Blood Pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	90.67 (9.19)	91.43 (9.98)	91.02 (9.57)
Systolic Blood Pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	151.23 (10.80)	151.11 (12.55)	151.17 (11.64)
Weight (Kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms]	85.41 (19.95)	89.17 (20.18)	87.16 (20.13)

Outcome Measures

1. Primary Outcome

Title	Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline
Description	Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment
Time Frame	14 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	392	357
Achieve Target Blood Pressure	276 59.6%	270 67.5%
Did not Achieve Target Blood Pressure	116 25.1%	87 21.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.118
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline
Description	Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	431	383
Achieve Target Blood Pressure	239 51.6%	231 57.8%
Did not Achieve Target Blood Pressure	192 41.5%	152 38%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.092
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline
Description	Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment
Time Frame	10 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	399	370
Achieve Target Blood Pressure	257 55.5%	254 63.5%
Did not Achieve Target Blood Pressure	142 30.7%	116 29%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.122
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline
Description	Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment
Time Frame	40 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 351 and 331 patients at week 40 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	351	331
Achieve Target Blood Pressure	264 57%	240 60%
Did not Achieve Target Blood Pressure	87 18.8%	91 22.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.434
	Comments
	Method	Fisher Exact
	Comments

5. Primary Outcome

Title	Change in Systolic Blood Pressure From Baseline to Week 14
Time Frame	14 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	392	357
Mean (Standard Deviation) [mm Hg]	-21.01 (14.11)	-22.74 (15.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.507
	Comments
	Method	Regression, Linear
	Comments	Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.

6. Primary Outcome

Title	Change in Diastolic Blood Pressure From Baseline to Week 14
Time Frame	14 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	392	357
Mean (Standard Deviation) [mm Hg]	-10.19 (9.33)	-12.05 (9.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.058
	Comments
	Method	Regression, Linear
	Comments	Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.

7. Secondary Outcome

Title	Change in Systolic Blood Pressure From Baseline to Week 6
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	431	383
Mean (Standard Deviation) [mm Hg]	-16.81 (14.92)	-18.85 (16.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.158
	Comments
	Method	Regression, Linear
	Comments	Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.

8. Secondary Outcome

Title	Change in Diastolic Blood Pressure From Baseline to Week 6
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	431	383
Mean (Standard Deviation) [mm Hg]	-8.34 (9.29)	-9.76 (9.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.064
	Comments
	Method	Regression, Linear
	Comments	Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.

9. Secondary Outcome

Title	Change in Systolic Blood Pressure From Baseline to Week 10
Time Frame	10 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	399	370
Mean (Standard Deviation) [mm Hg]	-19.11 (14.87)	-20.95 (16.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.262
	Comments
	Method	Regression, Linear
	Comments	Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.

10. Secondary Outcome

Title	Change in Diastolic Blood Pressure From Baseline to Week 10
Time Frame	10 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	399	370
Mean (Standard Deviation) [mm Hg]	-9.48 (8.80)	-11.42 (9.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	Regression, Linear
	Comments	Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.

11. Secondary Outcome

Title	Time to Achieve the Target Blood Pressure From Baseline
Description	Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).
Time Frame	14 Weeks

Outcome Measure Data

Analysis Population Description

463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 437 and 386 patients for L group and DML group respectively.

Arm/Group Title	Losartan-Based Regimen Alone (L Group)	Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.	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.
Measure Participants	437	386
Median (95% Confidence Interval) [Weeks]	7.43	6.57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan-Based Regimen Alone (L Group), Diet Management and Losartan-Based Regimen (DML Group)
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.212
	Comments
	Method	Log Rank
	Comments

Adverse Events

Adverse Event Reporting Description	A total of 8 patients were removed from the safety population because they did not receive at least one dose of the study medication. Therefore, the safety population was based on 984 patients (531 in the L Group and 453 in the DML Group) of the total 992 enrolled patients.
Arm/Group Title	Losartan-Based Regimen Alone (L Group)		Diet Management and Losartan-Based Regimen (DML Group)
Arm/Group Description	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.		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.
All Cause Mortality
	Losartan-Based Regimen Alone (L Group)		Diet Management and Losartan-Based Regimen (DML Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Losartan-Based Regimen Alone (L Group)		Diet Management and Losartan-Based Regimen (DML Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/531 (2.4%)		10/453 (2.2%)
Cardiac disorders
Acute myocardial infarction	0/531 (0%)		2/453 (0.4%)	2
Atrial fibrillation	1/531 (0.2%)	1	0/453 (0%)	1
Cardiac failure congestive	1/531 (0.2%)	1	0/453 (0%)	1
Cardio-respiratory arrest	1/531 (0.2%)	1	0/453 (0%)	1
Myocardial infarction	0/531 (0%)		2/453 (0.4%)	2
Palpitations	0/531 (0%)		1/453 (0.2%)	1
Supraventricular tachycardia	0/531 (0%)		1/453 (0.2%)	1
Tachycardia	0/531 (0%)		1/453 (0.2%)	1
Gastrointestinal disorders
Dry mouth	0/531 (0%)		1/453 (0.2%)	1
Oesophagitis	1/531 (0.2%)	1	0/453 (0%)	1
Pancreatitis acute	1/531 (0.2%)	1	0/453 (0%)	1
General disorders
Inflammation	0/531 (0%)		1/453 (0.2%)	1
Immune system disorders
Amyloidosis	0/531 (0%)		1/453 (0.2%)	1
Infections and infestations
Appendicitis	1/531 (0.2%)	1	0/453 (0%)	1
Diverticulitis	1/531 (0.2%)	1	0/453 (0%)	1
Gastroenteritis	0/531 (0%)		1/453 (0.2%)	1
Pneumonia	0/531 (0%)		1/453 (0.2%)	1
Injury, poisoning and procedural complications
Pseudocyst	1/531 (0.2%)	1	0/453 (0%)	1
Investigations
Blood creatine phosphokinase increased	0/531 (0%)		1/453 (0.2%)	1
Red blood cell sedimentation rate increased	0/531 (0%)		1/453 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	0/531 (0%)		1/453 (0.2%)	1
Metastases to bladder	1/531 (0.2%)	1	0/453 (0%)	1
Multiple myeloma	0/531 (0%)		1/453 (0.2%)	1
Prostate cancer metastatic	1/531 (0.2%)	1	0/453 (0%)	1
Nervous system disorders
Haemorrhagic stroke	1/531 (0.2%)	1	0/453 (0%)	1
Transient ischaemic attack	1/531 (0.2%)	1	0/453 (0%)	1
Renal and urinary disorders
Nephrolithiasis	1/531 (0.2%)	1	0/0 (NaN)	1
Renal failure acute	0/531 (0%)		1/453 (0.2%)	1
Reproductive system and breast disorders
Epididymitis	1/531 (0.2%)	1	0/453 (0%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/531 (0.2%)	1	0/453 (0%)	1
Skin and subcutaneous tissue disorders
Hyperhidrosis	0/531 (0%)		1/453 (0.2%)	1
Vascular disorders
Hypertension	0/531 (0%)		1/453 (0.2%)	1
Hypotension	1/531 (0.2%)	1	0/453 (0%)	1
Other (Not Including Serious) Adverse Events
	Losartan-Based Regimen Alone (L Group)		Diet Management and Losartan-Based Regimen (DML Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/531 (10.4%)		46/453 (10.2%)
Blood and lymphatic system disorders
Lymphadenopathy	0/531 (0%)		1/453 (0.2%)	1
Cardiac disorders
Arrhythmia	0/531 (0%)		1/453 (0.2%)	1
Palpitations	1/531 (0.2%)	1	0/453 (0%)	1
Eye disorders
Eye irritation	1/531 (0.2%)	1	0/453 (0%)	1
Vision blurred	1/531 (0.2%)	1	0/453 (0%)	1
Gastrointestinal disorders
Abdominal distension	1/531 (0.2%)	1	0/453 (0%)	1
Abdominal mass	1/531 (0.2%)	1	0/453 (0%)	1
Abdominal pain	2/531 (0.4%)	3	0/453 (0%)	3
Abdominal pain upper	1/531 (0.2%)	1	0/453 (0%)	1
Anal fissure	0/531 (0%)		1/453 (0.2%)	1
Diarrhoea	3/531 (0.6%)	5	2/453 (0.4%)	2
Dry mouth	0/531 (0%)		1/453 (0.2%)	1
Gastrooesophageal reflux disease	0/531 (0%)		1/453 (0.2%)	1
Nausea	2/531 (0.4%)	3	3/453 (0.7%)	3
Toothache	0/531 (0%)		1/453 (0.2%)	1
Vomiting	0/531 (0%)		1/453 (0.2%)	1
General disorders
Asthenia	1/531 (0.2%)	1	1/453 (0.2%)	1
Chest discomfort	1/531 (0.2%)	1	0/453 (0%)	1
Chest pain	2/531 (0.4%)	2	1/453 (0.2%)	1
Discomfort	1/531 (0.2%)	1	0/453 (0%)	1
Drug ineffective	2/531 (0.4%)	2	0/453 (0%)	2
Fatigue	4/531 (0.8%)	4	2/453 (0.4%)	2
Malaise	1/531 (0.2%)	1	0/453 (0%)	1
Oedema	1/531 (0.2%)	2	0/453 (0%)	2
Oedema peripheral	2/531 (0.4%)	2	1/453 (0.2%)	1
Immune system disorders
Drug hypersensitivity	3/531 (0.6%)	3	0/453 (0%)	3
Infections and infestations
Anal abscess	0/531 (0%)		1/453 (0.2%)	1
Bronchitis	0/531 (0%)		1/453 (0.2%)	1
Gastroenteritis	0/531 (0%)		1/453 (0.2%)	1
Helicobacter gastritis	1/531 (0.2%)	1	0/453 (0%)	1
Influenza	1/531 (0.2%)	1	0/453 (0%)	1
Lower respiratory tract infection	0/531 (0%)		1/453 (0.2%)	1
Nail infection	0/531 (0%)		1/453 (0.2%)	1
Nasopharyngitis	0/531 (0%)		1/453 (0.2%)	1
Sinusitis	1/531 (0.2%)	1	2/453 (0.4%)	2
Upper respiratory tract infection	0/531 (0%)		3/453 (0.7%)	3
Injury, poisoning and procedural complications
Drug exposure during pregnancy	1/531 (0.2%)	1	0/453 (0%)	1
Fall	0/531 (0%)		1/453 (0.2%)	1
Incorrect dose administered	1/531 (0.2%)	1	0/453 (0%)	1
Wrong technique in drug usage process	0/531 (0%)		1/453 (0.2%)	1
Investigations
Blood pressure decreased	1/531 (0.2%)	1	2/453 (0.4%)	2
Blood pressure increased	1/531 (0.2%)	1	1/453 (0.2%)	1
C-reactive protein abnormal	1/531 (0.2%)	1	0/453 (0%)	1
Creatinine urine increased	0/531 (0%)		1/453 (0.2%)	1
Heart rate increased	1/531 (0.2%)	1	0/453 (0%)	1
Urea urine increased	0/531 (0%)		1/453 (0.2%)	1
Urine output decreased	0/531 (0%)		1/453 (0.2%)	1
Urine sodium increased	0/531 (0%)		1/453 (0.2%)	1
Weight increased	0/531 (0%)		1/453 (0.2%)	1
White blood cell count abnormal	0/531 (0%)		1/453 (0.2%)	1
Metabolism and nutrition disorders
Decreased appetite	1/531 (0.2%)	1	0/453 (0%)	1
Diabetes mellitus	0/531 (0%)		1/453 (0.2%)	1
Dyslipidaemia	1/531 (0.2%)	1	0/453 (0%)	1
Fluid retention	0/531 (0%)		1/453 (0.2%)	1
Impaired fasting glucose	0/531 (0%)		1/453 (0.2%)	1
Type 2 diabetes mellitus	1/531 (0.2%)	1	0/453 (0%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	0/531 (0%)		1/453 (0.2%)	1
Back pain	2/531 (0.4%)	2	0/453 (0%)	2
Joint swelling	0/531 (0%)		1/453 (0.2%)	1
Muscle spasms	2/531 (0.4%)	2	2/453 (0.4%)	2
Musculoskeletal pain	0/531 (0%)		2/453 (0.4%)	2
Myalgia	3/531 (0.6%)	4	2/453 (0.4%)	2
Pain in extremity	1/531 (0.2%)	1	1/453 (0.2%)	1
Nervous system disorders
Dizziness	11/531 (2.1%)	11	6/453 (1.3%)	6
Dizziness postural	0/531 (0%)		1/453 (0.2%)	1
Headache	7/531 (1.3%)	8	6/453 (1.3%)	6
Hypoaesthesia	1/531 (0.2%)	2	0/453 (0%)	2
Somnolence	1/531 (0.2%)	1	0/453 (0%)	1
Syncope	0/531 (0%)		1/453 (0.2%)	1
Psychiatric disorders
Adjustment disorder	0/531 (0%)		1/453 (0.2%)	1
Anxiety	1/531 (0.2%)	1	2/453 (0.4%)	2
Depression	1/531 (0.2%)	1	1/453 (0.2%)	1
Insomnia	1/531 (0.2%)	1	0/453 (0%)	1
Personality disorder	0/531 (0%)		1/453 (0.2%)	1
Stress	1/531 (0.2%)	1	1/453 (0.2%)	1
Renal and urinary disorders
Microalbuminuria	0/531 (0%)		1/453 (0.2%)	1
Renal cyst	1/531 (0.2%)	1	0/453 (0%)	1
Erectile dysfunction	0/531 (0%)		1/453 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/531 (0.2%)	1	3/453 (0.7%)	3
Rhinitis allergic	0/531 (0%)		1/453 (0.2%)	1
Skin and subcutaneous tissue disorders
Rash	2/531 (0.4%)	2	1/453 (0.2%)	1
Rash maculo-papular	0/531 (0%)		1/453 (0.2%)	1
Surgical and medical procedures
Endometrial ablation	0/531 (0%)		1/453 (0.2%)	1
Vascular disorders
Hypertension	1/531 (0.2%)	1	1/453 (0.2%)	1
Hypotension	6/531 (1.1%)	6	2/453 (0.4%)	2
Labile blood pressure	0/531 (0%)		1/453 (0.2%)	1
Orthostatic hypotension	2/531 (0.4%)	2	1/453 (0.2%)	1

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

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.