HypertensionPhase 4KACTNCT00790946
Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)
A Phase 4 study testing Valsartan in people with Hypertension and Obesity, run by Kagoshima University at 1 site in Japan.
Trial summary
The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Obesity
- What is being tested?
- Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2006to Dec 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Out patients with hypertension male and female
- Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg
- Waist Surrounding diameter male≧85cm female≧90cm
- Patient who is treating either high triglyceride,low HDL,or diabetes mellitus
- Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol < 40 mg/dl or fasting blood glucose ≧110 mg/dl
- Untreated patients with hypertension,or patients is treated with antihypertensive agents except for ACE-I and ARB
Who cannot join
- Patient who is using ACE-I and ARB
- Serum creatinine ≧ 3 mg/dl
- Liver impairment
- History of allergy to valsartan
- Pregnant women
- Judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety
Trial locations and contacts
1 site in 1 country.
Chuwa Tei, MD, PhD contact
Japan1 site, 1 recruiting
- Recruiting
Chuwa Tei,MD,FACC,FAHA
Kagoshima, Kagoshima-ken, 890-8520
Chuwa Tei, MD,FACC,FAHA, tei@m.kufm.kagoshima-u.ac.jp
Masaaki Miyata, MD,PhD、FACC, miyatam@m3.kufm.kagoshima-u.ac.jp
About this study
Official title: Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension
The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment.
- Blood pressure control
- Changing of adiponectin and plasminogen activator inhibitor-1
- Influence metabolizing and cardiac function, etc.
Read the detailed description
The primary endpoints are:
- blood pressure control
- Adiponectin and plasma type1 plasminogen active inhibitor
The secondary endpoints are
- HOMA-IR
- HbA1c
- TNF-α
- IL-6
- Plasma B-type natriuretic peptide
- LVMI
- E/A ratio
- Tei-index
- Apo-J
- Conditions
- Hypertension, Obesity
- Being tested
- Valsartan
- Keywords
- valsartan, Metabolic syndrome
- Medical subject headings
- Hypertension, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Valsartan 80 to 160 mg
| Study group | Role | What they receive |
|---|---|---|
| Valsartan | Active comparator | Valsartan 80 to 160mg Receives: Drug: Valsartan |
| standard therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure, Adiponectin and PAI-1 concentration
Measured: 1 year
Secondary outcomes (9)
HOMA-IR
Measured: 1 year
HbA1c
Measured: 1 year
TNF-α
Measured: １ year
IL-6
Measured: 1 year
BNP
Measured: 1 year
LVMI
Measured: 1 year
E/A ratio
Measured: 1 year
Tei-index
Measured: 1 year
Apo-J
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJun 2006
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kagoshima University
- Sponsor type
- University, hospital or other
- Investigators
- Chuwa Tei, MD, PhD, Study chair, Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790946
- Sponsor's protocol ID
- CVM-RCT-2006-06
- Acronym
- KACT
- Status last verified
- Dec 2008
- First submitted
- 10 Oct 2008
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miyata M, Ikeda Y, Nakamura S, Sasaki T, Abe S, Minagoe S, Torii H, Lee S, Tateishi S, Kihara K, Ohba I, Kajiya S, Furusho Y, Hamasaki S, Tei C; Kagoshima Collaborate Trial in Metabolic Syndrome (KACT-MetS) Investigators. Effects of valsartan on fibrinolysis in hypertensive patients with metabolic syndrome. Circ J. 2012;76(4):843-51. doi: 10.1253/circj.cj-12-0153.
PubMed 22451451
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT00790946
- Acronym / sponsor ID
- KACT / CVM-RCT-2006-06
- Conditions
- Hypertension, Obesity
- Keywords
- valsartan, Metabolic syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kagoshima UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 14 Nov 2008 (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.
The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment.
- Blood pressure control
- Changing of adiponectin and plasminogen activator inhibitor-1
- Influence metabolizing and cardiac function, etc.
Detailed description
The primary endpoints are:
- blood pressure control
- Adiponectin and plasma type1 plasminogen active inhibitor
The secondary endpoints are
- HOMA-IR
- HbA1c
- TNF-α
- IL-6
- Plasma B-type natriuretic peptide
- LVMI
- E/A ratio
- Tei-index
- Apo-J
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan | Active comparator | Drug: ValsartanValsartan 80 to 160mg |
| standard therapy | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Out patients with hypertension male and female
- Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg
- Waist Surrounding diameter male≧85cm female≧90cm
- Patient who is treating either high triglyceride,low HDL,or diabetes mellitus
- Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol < 40 mg/dl or fasting blood glucose ≧110 mg/dl
Key exclusion criteria (6 listed)
- Patient who is using ACE-I and ARB
- Serum creatinine ≧ 3 mg/dl
- Liver impairment
- History of allergy to valsartan
- Pregnant women
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 |
|---|---|---|
| ValsartanValsartan 80 to 160 mg | Drug | Valsartan |
Primary outcome
Blood Pressure, Adiponectin and PAI-1 concentration
Time frame: 1 year
9 secondary outcomes
HOMA-IR
Time frame: 1 year
HbA1c
Time frame: 1 year
TNF-α
Time frame: １ year
IL-6
Time frame: 1 year
BNP
Time frame: 1 year
LVMI
Time frame: 1 year
E/A ratio
Time frame: 1 year
Tei-index
Time frame: 1 year
Apo-J
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
- Derived from this study: PubMed 22451451Miyata M, Ikeda Y, Nakamura S, Sasaki T, Abe S, Minagoe S, Torii H, Lee S, Tateishi S, Kihara K, Ohba I, Kajiya S, Furusho Y, Hamasaki S, Tei C; Kagoshima Collaborate Trial in Metabolic Syndrome (KACT-MetS) Investigators. Effects of valsartan on fibrinolysis in hypertensive patients with metabolic syndrome. Circ J. 2012;76(4):843-51. doi: 10.1253/circj.cj-12-0153.
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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.
Chuwa Tei, MD, PhD contact
Chuwa Tei, MD, PhD study chair
Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University
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 Valsartan in people with Hypertension and Obesity, run by Kagoshima University 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Jun 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuwa Tei, MD, PhD (tei@m.kufm.kagoshima-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure, Adiponectin and PAI-1 concentration (time frame: 1 year). 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 NCT00790946, which also lists 1 linked publication.
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 3 Jun 2010.