A 52 Week Study to Evaluate the Effects of Losartan With or Without HCTZ on Plasma Glucose, Metabolic Parameters, Blood Pressure in Hypertensive Patients With Metabolic Syndrome (0954A-331)

NCT00546052 | Completed Phase 3 Results

• 3 other identifiers: 0954A-331MK0954A-3312007_030
• Study Type: interventional
• Target: 1,738
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.

Conditions

Hypertension; Metabolic Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin A1c Between 52 Weeks and Baseline

  Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.

  52 Weeks - Baseline

• Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments

  Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.

  52 Weeks - Baseline

Secondary Outcomes (3)

• Target Blood Pressure

  52 Weeks

• Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments

  52 Weeks - Baseline

• Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments

  52 Weeks - Baseline

Other Outcomes (8)

• Change in Waist Circumference Between Baseline and 52 Week Assessments

  52 Weeks - Baseline

• Change in Body Mass Index Between Baseline and 52 Week Assessments

  52 Weeks - Baseline

• Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments

  52 Weeks - Baseline

Study Arms (1)

1

EXPERIMENTAL

Losartan (MK0954) / Losartan + HCTZ (MK0954A)

Drug: losartan potassium (+) hydrochlorothiazide

Interventions

losartan potassium (+) hydrochlorothiazide DRUG

All patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year.

Also known as: Cozaar/Hyzaar

1

Eligibility Criteria

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

You may qualify if:

• An Adult Patient (At Least 18 Years Of Age) With A Clinical Identification Of The Metabolic Syndrome Using The IDF Definition:
• abdominal (central) obesity as defined by the waist circumference in men of \> 102 cm and women of \> 88 cm or a BMI equal or greater than 30 kg/m2
• and untreated hypertension with bp equal or greater than 140/90 mm Hg but bp \< 180/110 mm Hg
• or a patient receiving one or two antihypertensive agent(s) (diuretics, ace inhibitors, angiotensin ii receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) and whose blood pressure is not controlled:
• bp equal or greater than 140/90 mm Hg but equal or less than 160/100 mm Hg
• or a patient whose hypertension is controlled (\< 140/90 mm hg) with a single anti-hypertensive agent (diuretics, ace inhibitors, and angiotensin II receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) but who is unsatisfied or experiencing side effects warranting a discontinuation of the previous treatment and at one of the following:
• Fasting plasma glucose equal or greater than 5.6 mmol/L and \< 7.0 mmol/L
• Triglycerides \> 1.7 mmol/L or specific treatment for this lipid abnormality
• HDL-c in men \< 0.9 mmol/L and in women \< 1.1 mmol/L or specific treatment for this lipid abnormality

You may not qualify if:

• A Patient With A Diagnosis Of Type II Diabetes Defined As Fasting Blood Glucose Level Equal Or Greater Than 7.0 Mmol/L Or A 2hpg In A 75-G OGTT Equal Or Greater Than 11.1 Mol/L Or Using Any Anti-Hyperglycemic Agents
• Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Or Hypertensive Encephalopathy)
• Patient Intolerant To Any Component Of Losartan 50 Mg / Losartan 100 Mg / Losartan 100 Mg + Hctz 12.5 Mg / Losartan 100 Mg + Hctz 25 Mg Or With A Documented History Of Angioedema
• Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance On The Basis Of The Case History Or A Recent Laboratory Test (Serum Creatinine \> 130 Mmol/L Or Creatinine Clearance \< 45 Ml/Min, Ast \> 2 Times Above The Normal Range, Alt \> 2 Times Above The Normal Range, Serum Potassium \< 3.5 Or \> 5.5 Meq/L)
• Patient With Symptomatic Heart Failure (Classes 3 And 4)
• Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
• Patient Who Has Undergone Percutaneous Coronary Angioplasty Or Coronary Artery Bypass Within The Last 3 Months
• Pregnant Woman Or A Woman Of Childbearing Potential

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Racine N, Hamet P, Sampalis JS, Longo N, Bastien N. A 52-week prospective, cohort study of the effects of losartan with or without hydrochlorothiazide (HCTZ) in hypertensive patients with metabolic syndrome. J Hum Hypertens. 2010 Nov;24(11):739-48. doi: 10.1038/jhh.2010.3. Epub 2010 Feb 11.

  PMID: 20147971 RESULT

MeSH Terms

Conditions

Hypertension; Metabolic Diseases

Interventions

hydrochlorothiazide, losartan drug combination; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 18, 2007
• Study Start: September 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 16, 2024
• Results First Posted: June 23, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share