Hypertension Control Based on Home Blood Pressure
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Amlodipine, Losartan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hypertension Control Based on Home Systolic Pressure Study (HOSP Study) |
- Combined cardiovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Total mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Cardiovascular mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Myocardial infarction and new-onset angina [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Stroke and transient ischemic attack [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Renal failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Aortic and peripheral artery diseases [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Left ventricular mass and function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Urinary albumin and renal function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2600 |
| Study Start Date: | April 2000 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)
|
Drug: Amlodipine, Losartan
amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years
Other Name: other antihypertensive drugs (if required)
|
|
Active Comparator: 2
antihypertensive drug (amlodipine vs losartan)
|
Drug: Amlodipine, Losartan
amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years
Other Name: other antihypertensive drugs (if required)
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of hypertension
Exclusion Criteria:
- Severe hypertension (treated with 3 or more antihypertensive drugs)
- Unable to change antihypertensive drugs to a calcium antagonist or an angiotensin antagonist
- Serious medical conditions
- Women who may become to be pregnant
Contacts and Locations| Japan | |
| National Cardiovascular Center | |
| Suita, Osaka, Japan, 565-8565 | |
| Principal Investigator: | Yuhei Kawano, M.D., Ph.D. | Division of Hypertension and Nephrology, National Cardiovascular Center |
More Information
No publications provided
| Responsible Party: | Yuhei Kawano, M.D., Ph.D., Director of Division of Hypertension and Nephrology, National Cardiovascular Center |
| ClinicalTrials.gov Identifier: | NCT00198562 History of Changes |
| Other Study ID Numbers: | H16-CV-001, 200400510B |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 18, 2008 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Ministry of Health, Labour and Welfare, Japan:
|
Antihypertensive therapy Home blood pressure Systolic blood pressure |
Morning blood pressure Calcium antagonist Angiotensin receptor antagonist |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Antihypertensive Agents Amlodipine Losartan Angiotensin Receptor Antagonists Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers |
ClinicalTrials.gov processed this record on May 19, 2013