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)

Hypertension Clinical Trial

Official title:

52 Week Study to Evaluate the Effects of LOSARTAN 50 mg, 100 mg, 100/12.5 mg HCTZ, 100/25 mg HCTZ on Metabolic Parameters, Blood Pressure and Safety in Hypertensive Patients With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546052
• Other study ID #: 0954A-331
• Secondary ID: MK0954A-3312007_
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2005
• Est. completion date: January 1, 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1738
• Est. completion date: January 1, 2008
• Est. primary completion date: January 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypertension
• Metabolic Diseases
• Metabolic Disorder
• Metabolic Syndrome

Intervention

Drug:
• losartan potassium (+) hydrochlorothiazide
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Waist Circumference Between Baseline and 52 Week Assessments	Absolute change in Waist Circumference between baseline and 52 week assessments	52 Weeks - Baseline
Other	Change in Body Mass Index Between Baseline and 52 Week Assessments	Absolute change in Body Mass Index Baseline and 52 week assessments	52 Weeks - Baseline
Other	Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments	Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks - LDL-C Baseline) / (LDL-C Baseline)].	52 Weeks - Baseline
Other	Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments	Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks - HDL-C 52 Baseline) / (HDL-C Baseline)].	52 Weeks - Baseline
Other	Percent Change in Triglycerides Between Baseline and 52 Week Assessments	Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks - Triglycerides Baseline) / (Triglycerides Baseline)].	52 Weeks - Baseline
Other	Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments	Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks - Total Cholesterol Baseline) / (Total Cholesterol Baseline)].	52 Weeks - Baseline
Other	Absolute Change in Uric Acid Between Baseline and 52 Week Assessments	Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks - Uric Acid Baseline.	52 Weeks - Baseline
Other	Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments	Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks - C Reactive Protein Baseline.	52 Weeks - Baseline
Primary	Change in Hemoglobin A1c Between 52 Weeks and Baseline	Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.	52 Weeks - Baseline
Primary	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	Target Blood Pressure	Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure = 140/90 mm Hg at 52 weeks	52 Weeks
Secondary	Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments	Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.	52 Weeks - Baseline
Secondary	Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments	Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.	52 Weeks - Baseline