AgedPhase 4VALISHNCT00151229

Valsartan in Elderly Isolated Systolic Hypertension Study

A Phase 4 study testing target blood pressure in people with Aged and Systolic Hypertension, run by VALISH study at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with valsartan in elderly isolated systolic hypertensive patients in Japan. Read more about this study

Who is it for?: Ages 70 to 85 years
Conditions the study is for: Aged, Systolic Hypertension
What is being tested?: target blood pressure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,079 participants
Where: 1 siteJapan
Study dates: Oct 2003to Mar 2008
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 to 85 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

Outpatients aged over 70 years and less than 85 years, regardless of sex.
Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks.
Previously untreated patients or patients who are on other therapy that can be converted to valsartan.

Who cannot join

Patients with secondary hypertension or malignant hypertension.
Patients with seated systolic blood pressure of over 200 mmHg.
Patients with seated diastolic blood pressure of over 90 mmHg.
Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study.
Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry.
Patients with severe heart failure (NYHA functional classification III and IV).

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Patients with severe aortic stenosis or valvular disease.
Patients with atrial fibrillation, atrial flutter, or serious arrhythmia.
Patients with renal dysfunction with serum creatinine level of over 2 mg/dL.
Patients with serious liver dysfunction.
Patients with a history of hypersensitivity to valsartan.
Other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

VALISH Data Center
ING Corporation, 8-21, Shinjuku-ku, Tokyo, 162-0067

Other trials in Japan

About this study

Official title: Valsartan in Elderly Isolated Systolic Hypertension

Read the detailed description

Although antihypertensive therapy has been proven to reduce cardiovascular morbidity and mortality, it is unclear how much blood pressure should be decreased in elderly patients with hypertension. The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study is a multicenter parallel-group study comparing the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg, under treatment with valsartan, an angiotensin II receptor blocker, as an initial antihypertensive drug in elderly patients with isolated systolic hypertension. The number of patients to be recruited is 3,000 and the duration of follow-up is at least 2 years. This 3,000-patient trial was designed with a two-sided α level of 0.05 and 80% power to detect the difference in incidence of cardiovascular events between the target blood pressure levels based on estimation of the cardiovascular events ratio as 21.5/1,000 patient-years and 29.1/1,000 patient-years for the two blood pressure levels. The VALISH study, a large-scale investigator-initiated trial in Japan, will determine whether age should be considered in setting target blood pressure in treatment of isolated systolic hypertension in elderly patients.

Conditions: Aged, Systolic Hypertension
Being tested: target blood pressure
Keywords: isolated systolic hypertension, valsartan, target blood pressure
Medical subject headings: Isolated Systolic Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

target blood pressureOther

Study groups in NCT00151229
Study group	Role	What they receive
strict control	Active comparator	systolic blood pressure control: less than 140 mm Hg Receives: Other: target blood pressure
moderate control	Active comparator	systolic blood pressure control: 140 mm Hg to 149 mm Hg Receives: Other: target blood pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

composite cardiovascular events
sudden death, fatal or nonfatal stroke, fatal or nonfatal myocardial infarction, death because of heart failure, other cardiovascular death, unplanned hospitalization for cardiovascular disease, and renal dysfunction (doubling of serum creatinine to a level 2.0 mg per 100 mL or introduction of dialysis).
Measured: participants will be followed for the duration of the study, an expected median follow-up 3.07 years

Secondary outcomes (6)

sudden death
Measured: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
stroke
Measured: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
myocardial infarction
Measured: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
heart failure
Measured: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
hospitalization
Measured: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
renal disorder
Measured: participants will be followed for the duration of the study, an expected median follow-up 3.07 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2003Mar 2008

First posted8 Sep 2005 (estimated)
Study startOct 2003
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for AgedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3,079 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00151229
Sponsor's protocol ID: VAL-200310
Acronym: VALISH
Status last verified: Jun 2015
First submitted: 7 Sep 2005
Last updated: 4 Jun 2015
Results posted: No
Data monitoring committee: Yes

Publications

Ogihara T, Saruta T, Matsuoka H, Shimamoto K, Fujita T, Shimada K, Imai Y, Nishigaki M. valsartan in elderly isolated systolic hypertension (VALISH) study: rationale and design. Hypertens Res. 2004 Sep;27(9):657-61. doi: 10.1291/hypres.27.657.
PubMed 15750259
Ogihara T, Saruta T, Rakugi H, Matsuoka H, Shimamoto K, Shimada K, Imai Y, Kikuchi K, Ito S, Eto T, Kimura G, Imaizumi T, Takishita S, Ueshima H; Valsartan in Elderly Isolated Systolic Hypertension Study Group. Target blood pressure for treatment of isolated systolic hypertension in the elderly: valsartan in elderly isolated systolic hypertension study. Hypertension. 2010 Aug;56(2):196-202. doi: 10.1161/HYPERTENSIONAHA.109.146035. Epub 2010 Jun 7.
PubMed 20530299
Yano Y, Rakugi H, Bakris GL, Lloyd-Jones DM, Oparil S, Saruta T, Shimada K, Matsuoka H, Imai Y, Ogihara T. On-Treatment Blood Pressure and Cardiovascular Outcomes in Older Adults With Isolated Systolic Hypertension. Hypertension. 2017 Feb;69(2):220-227. doi: 10.1161/HYPERTENSIONAHA.116.08600. Epub 2017 Jan 3.
PubMed 28049699

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Valsartan in Elderly Isolated Systolic Hypertension
ClinicalTrials.gov ID: NCT00151229
Acronym / sponsor ID: VALISH / VAL-200310
Conditions: Aged, Systolic Hypertension
Keywords: isolated systolic hypertension, valsartan, target blood pressure
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,079 participants (actual)
Lead sponsor: VALISH studyUniversity, hospital or other
Collaborators: Japan Cardiovascular Research Foundation
Study start: Oct 2003
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 8 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
strict control	Active comparator	Other: target blood pressuresystolic blood pressure control: less than 140 mm Hg
moderate control	Active comparator	Other: target blood pressuresystolic blood pressure control: 140 mm Hg to 149 mm Hg

Who may qualify

Ages: 70 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Outpatients aged over 70 years and less than 85 years, regardless of sex.
Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks.
Previously untreated patients or patients who are on other therapy that can be converted to valsartan.

Key exclusion criteria (12 listed)

Patients with secondary hypertension or malignant hypertension.
Patients with seated systolic blood pressure of over 200 mmHg.
Patients with seated diastolic blood pressure of over 90 mmHg.
Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study.
Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
target blood pressure	Other	moderate control, strict control

Primary outcome

composite cardiovascular events
Time frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
sudden death, fatal or nonfatal stroke, fatal or nonfatal myocardial infarction, death because of heart failure, other cardiovascular death, unplanned hospitalization for cardiovascular disease, and renal dysfunction (doubling of serum creatinine to a level 2.0 mg per 100 mL or introduction of dialysis).

6 secondary outcomes

sudden death
Time frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
stroke
Time frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
myocardial infarction
Time frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
heart failure
Time frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
hospitalization
Time frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years
renal disorder
Time frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
Background: PubMed 15750259Ogihara T, Saruta T, Matsuoka H, Shimamoto K, Fujita T, Shimada K, Imai Y, Nishigaki M. valsartan in elderly isolated systolic hypertension (VALISH) study: rationale and design. Hypertens Res. 2004 Sep;27(9):657-61. doi: 10.1291/hypres.27.657.
Results publication: PubMed 20530299Ogihara T, Saruta T, Rakugi H, Matsuoka H, Shimamoto K, Shimada K, Imai Y, Kikuchi K, Ito S, Eto T, Kimura G, Imaizumi T, Takishita S, Ueshima H; Valsartan in Elderly Isolated Systolic Hypertension Study Group. Target blood pressure for treatment of isolated systolic hypertension in the elderly: valsartan in elderly isolated systolic hypertension study. Hypertension. 2010 Aug;56(2):196-202. doi: 10.1161/HYPERTENSIONAHA.109.146035. Epub 2010 Jun 7.
Derived from this study: PubMed 28049699Yano Y, Rakugi H, Bakris GL, Lloyd-Jones DM, Oparil S, Saruta T, Shimada K, Matsuoka H, Imai Y, Ogihara T. On-Treatment Blood Pressure and Cardiovascular Outcomes in Older Adults With Isolated Systolic Hypertension. Hypertension. 2017 Feb;69(2):220-227. doi: 10.1161/HYPERTENSIONAHA.116.08600. Epub 2017 Jan 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Toshio Ogihara, MD, PhD principal investigator

Department of Geriatric Medicine, Osaka University Graduate School of Medicine

Takao Saruta, MD, PhD principal investigator

Department of Internal Medicine, Keio University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing target blood pressure in people with Aged and Systolic Hypertension, run by VALISH study at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite cardiovascular events (time frame: participants will be followed for the duration of the study, an expected median follow-up 3.07 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00151229, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.