NCT00417222

Brief Summary

The purpose of this study is to investigate whether an angiotensin II receptor blocker (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity in hypertensive patients with stable chronic heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,145

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

6.3 years

First QC Date

December 28, 2006

Last Update Submit

May 16, 2014

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • A composite of the following outcomes 1) all-cause death 2) nonfatal acute myocardial infarction 3) nonfatal stroke 4) hospital admission due to congestive heart failure

    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

    by the end of the study

Secondary Outcomes (13)

  • cardiovascular death

    by the end of the study

  • death due to heart failure

    by the end of the study

  • sudden death

    by the end of the study

  • acute myocardial infarction

    by the end of the study

  • stroke

    by the end of the study

  • +8 more secondary outcomes

Other Outcomes (1)

  • serum markers for metabolic syndrome

    three years

Study Arms (2)

Olmesartan medoxomil

ACTIVE COMPARATOR

olmesartan medoxomil

Drug: olmesartan medoxomil

Standard therapy

NO INTERVENTION

Standard therapy

Interventions

olmesartan medoxomilDRUG

5 to 40mg P.O. daily until the end of the study

Olmesartan medoxomil

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who meet all of the following criteria.
  • Patients with NYHA class II through IV chronic heart failure.
  • Patients who have a history of hypertension or those who have antihypertensive medications.
  • Patients who are aged 20 years or older and less than 80 years at the entry.
  • Stable patients who have angiotensin converting enzyme inhibitor and/or beta-blocker.
  • Patients who do not have angiotensin II receptor blocker.

You may not qualify if:

  • Patients who have renal dysfunction (serum creatinine \>=3.0mg/dL) or those who are receiving chronic hemodialysis.
  • History of drug hypersensitivity to olmesartan.
  • Patients who have severe liver dysfunction.
  • History of angioedema.
  • History of malignant tumor or life-threatening illness of poor prognosis.
  • Pregnant or possibly pregnant patients.
  • Cardiovascular surgery within 6months prior to the date of the entry.
  • Acute myocardial infarction within 6 months prior to the date of the entry.
  • Percutaneous coronary intervention or stent implantation within 6 months prior to the date of the entry.
  • Other patients deemed unsuitable as subjects of the study by the treating physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

Sendai, 980-8574, Japan

Location

Related Publications (1)

  • Sakata Y, Shiba N, Takahashi J, Miyata S, Nochioka K, Miura M, Takada T, Saga C, Shinozaki T, Sugi M, Nakagawa M, Sekiguchi N, Komaru T, Kato A, Fukuchi M, Nozaki E, Hiramoto T, Inoue K, Goto T, Ohe M, Tamaki K, Ibayashi S, Ishide N, Maruyama Y, Tsuji I, Shimokawa H; SUPPORT Trial Investigators; SUPPORT Trial Investigators. Clinical impacts of additive use of olmesartan in hypertensive patients with chronic heart failure: the supplemental benefit of an angiotensin receptor blocker in hypertensive patients with stable heart failure using olmesartan (SUPPORT) trial. Eur Heart J. 2015 Apr 14;36(15):915-23. doi: 10.1093/eurheartj/ehu504. Epub 2015 Jan 30.

    PMID: 25637937DERIVED

MeSH Terms

Interventions

Olmesartan Medoxomil

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Hiroaki Shimokawa, MD, PhD

    Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2006

First Posted

December 29, 2006

Study Start

November 1, 2006

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations

JP(1)