Isolated Systolic Hypertension in the Elderly and Very Elderly

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Isolated Systolic Hypertension

Treatments: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary; Drug: nitrendipine + hydrochlorothiazide, if necessary

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751829

SE-866/37

Details and patient eligibility

About

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.

Enrollment: 417 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

417 participants in 2 patient groups

1

Experimental group

Description:

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 controll BP

Treatment:

Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary

2

Active Comparator group

Description:

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

Treatment:

Drug: nitrendipine + hydrochlorothiazide, if necessary