NCT00198562

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,600

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

Enrollment Period

11.9 years

First QC Date

September 12, 2005

Last Update Submit

April 18, 2008

Conditions

Hypertension

Keywords

Antihypertensive therapyHome blood pressureSystolic blood pressureMorning blood pressureCalcium antagonistAngiotensin receptor antagonist

Outcome Measures

Primary Outcomes (1)

  • Combined cardiovascular events

    5 years

Secondary Outcomes (8)

  • Total mortality

    5 years

  • Cardiovascular mortality

    5 years

  • Myocardial infarction and new-onset angina

    5 years

  • Stroke and transient ischemic attack

    5 years

  • Renal failure

    5 years

  • +3 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

target morning home blood pressure (below 130 mmHg vs 130-139 mmHg)

Drug: Amlodipine, Losartan

2

ACTIVE COMPARATOR

antihypertensive drug (amlodipine vs losartan)

Drug: Amlodipine, Losartan

Interventions

Amlodipine, LosartanDRUG

amlodipine: 2.5-10 mg once daily for 5 years losartan: 25-100 mg once daily for 5 years

Also known as: other antihypertensive drugs (if required)
12

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of hypertension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

amlodipine-losartan drug combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Yuhei Kawano, M.D., Ph.D.

    Division of Hypertension and Nephrology, National Cardiovascular Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2000

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

JP(1)