Trials / Unknown
UnknownNCT00198562
Hypertension Control Based on Home Blood Pressure
Hypertension Control Based on Home Systolic Pressure Study (HOSP Study)
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 2,600 (estimated)
- Sponsor
- Ministry of Health, Labour and Welfare, Japan · Other Government
- Sex
- All
- Age
- 40 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs. The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. The study subjects are 40-79 years old hypertensive patients. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (morning home BP \<140 mmHg) or (2) strict control group (morning home BP \<130 mmHg), and to (a) amlodipine group or (b) losartan group. Additional antihypertensive drugs can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. The participants will be followed up for 5 years.
Detailed description
The aim of this trial is to study the effects of antihypertensive therapy based on home systolic blood pressure (BP) with different target levels using two classes of drugs. The HOSP study is a multicenter, prospective, randomized, open, blinded endpoint study. Inclusion criteria are 40-79 years old treated or untreated hypertensive patients without serious medical conditions. After a 4 weeks of baseline period, subjects are randomly assigned to (1) modest control group (target morning home BP \<140 mmHg) or (2) strict control group (morning home BP \<130 mmHg), and to (a) amlodipine group (2.5-5 mg od) or (b) losartan group (25-50 mg od). Additional antihypertensive drugs (diuretics, beta-blockers and alpha-blockers) can be used if home BP is not controlled. Home BP is measured in the early morning and late evening. Primary end point is combined cardiovascular events.The participants will be followed up for 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amlodipine, Losartan | amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years |
Timeline
- Start date
- 2000-04-01
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2005-09-20
- Last updated
- 2008-04-22
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00198562. Inclusion in this directory is not an endorsement.