Clinical trial
Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension
Name
SE-866/37
Description
To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.
Trial arms
Trial start
2003-07-01
Estimated PCD
2004-10-01
Trial end
2005-02-01
Status
Completed
Phase
Early phase I
Treatment
olmesartan medoxomil + hydrochlorothiazide, if necessary
oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
Arms:
1
nitrendipine + hydrochlorothiazide, if necessary
oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
Arms:
2
Size
417
Primary endpoint
Change in mean sitting systolic blood pressure as assessed by conventional BP measurements
12 weeks
Eligibility criteria
Inclusion Criteria:
* Age 65 or older
* Mean sitting BP \>160 mmHg and mean sitting dBP\<90 mmHg
Exclusion Criteria:
* Secondary hypertension
* Malignant hypertension
* Severe Heart Failure (NYHA III-IV)
* Recent history of myocardial infarction
* Hypersensitivity to study medications
* History of drug or alcohol abuse
* History or evidence of renal disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 417, 'type': 'ACTUAL'}}
Updated at
2023-06-01
1 organization
2 products
1 indication
Organization
Daiichi Sankyo EuropeIndication
Hypertension