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

NCT00739674 | Completed Phase 3 Results

• 3 other identifiers: 0954A-3352008_022MK0954A-335
• Study Type: interventional
• Target: 992
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline

  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

  14 Weeks

• Change in Systolic Blood Pressure From Baseline to Week 14

  14 Weeks

• Change in Diastolic Blood Pressure From Baseline to Week 14

  14 Weeks

Secondary Outcomes (8)

• Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline

  6 Weeks

• Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline

  10 Weeks

• Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline

  40 Weeks

• Change in Systolic Blood Pressure From Baseline to Week 6

  6 Weeks

• Change in Diastolic Blood Pressure From Baseline to Week 6

  6 Weeks

Study Arms (2)

Losartan-Based Regimen Alone (L Group)

ACTIVE COMPARATOR

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])

Diet Management and Losartan-Based Regimen (DML Group)

EXPERIMENTAL

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]); Behavioral: Low Salt Diet

Interventions

losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) DRUG

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

Diet Management and Losartan-Based Regimen (DML Group); Losartan-Based Regimen Alone (L Group)

Low Salt Diet BEHAVIORAL

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)

Diet Management and Losartan-Based Regimen (DML Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypertension

Interventions

Losartan; Hydrochlorothiazide; Calcium Channel Blockers; Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 22, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 16, 2024
• Results First Posted: August 11, 2010

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share