Phase 3
Completed N=1,738
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 · Metabolic Disorder
Source: ClinicalTrials.gov NCT00546052 ↗
Enrolled (actual)
1,738
Serious AEs
2.0%
Results posted
Jun 2009
Primary outcomePrimary: Change in Hemoglobin A1c Between 52 Weeks and Baseline — 0.04 Percent — p=0.999
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1c Between 52 Weeks and Baseline |
0.04 | 0.999 |
| PRIMARY Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments |
0.02 | 0.999 |
| SECONDARY Target Blood Pressure |
1200; 1200; 1200; 538; 514; 311 | — |
| SECONDARY Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments |
-16.95 | <0.001 sig |
| SECONDARY Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments |
-9.84 | <0.001 sig |
Eligibility Criteria
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 1.7 mmol/L or specific treatment for this lipid abnormality
- HDL-c in men 130 Mmol/L Or Creatinine Clearance 2 Times Above The Normal Range, Alt > 2 Times Above The Normal Range, Serum Potassium 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
Data sourced from ClinicalTrials.gov (NCT00546052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.