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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 16, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Hypertension
Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])
Behavioral: Low Salt Diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    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

  • Change in Systolic Blood Pressure From Baseline to Week 14 [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 14 [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    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

  • Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
    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

  • Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline [ Time Frame: 40 Weeks ] [ Designated as safety issue: No ]
    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

  • Change in Systolic Blood Pressure From Baseline to Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • Time to Achieve the Target Blood Pressure From Baseline [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).


Enrollment: 992
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739674

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

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 16, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Calcium Channel Blockers
Hydrochlorothiazide
Losartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014