Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly
Sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
About this trial
Last updated 17 years ago
Study ID
SE-866/36
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
65+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 20 years ago
What is this trial about?
To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to
losartan in elderly and very elderly patients with essential hypertension. The study
hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean
sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study
duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment
hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements
are carried out at up to 18 visits during the trial.
What are the participation requirements?
Inclusion Criteria
- Age 65 years or older
- Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP >=150 mm HG
Exclusion Criteria
- Secondary hypertension
- Malignant hypertension
- Severe heart failure (NYHA III-IV)
- History or evidence of renal disease
- Recent history of myocardial infarction
- Hypersensitivity to study drugs
- History of drug or alcohol abuse