Cardiovascular DiseaseNCT00530595
Effects of Angiotensin Receptor Antagonist on Prohibiting Cardiovascular Events on Hemodialysis Patients
A study testing candesartan or valsartan or losartan in people with Cardiovascular Disease, run by Saitama Medical University.
Trial summary
Cardiovascular disease is a leading cause of mortality in patients on hemodialysis therapy (HD), accounting for 30 to 50% of all death. Although angiotensin receptor blockers (ARBs) are effective for patients with diabetes and chronic kidney disease in reducing or preventing cardiovascular diseases, there has been no… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- candesartan or valsartan or losartan
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30 to 80 years of age
- Receiving hemodialysis at least 12 months and less than 5 years
- Pre-dialysis systolic blood pressure was more than 160 mmHg, or more than 150 mmHg if the patients received antihypertensive agents.
Who cannot join
- Use of angiotensin receptor blocker or angiotensin converting enzyme inhibitor
About this study
Cardiovascular disease is a leading cause of mortality in patients on hemodialysis therapy (HD), accounting for 30 to 50% of all death. Although angiotensin receptor blockers (ARBs) are effective for patients with diabetes and chronic kidney disease in reducing or preventing cardiovascular diseases, there has been no decisive study that demonstrated treatment with ARBs is effective in patients on HD.
- Conditions
- Cardiovascular Disease
- Being tested
- candesartan or valsartan or losartan
- Keywords
- hemodialysis
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartan or valsartan or losartanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (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 Cardiovascular DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Saitama Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Hiromichi Suzuki, MD, PhD, Study director, Department of Nephrology, Saitama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530595
- Sponsor's protocol ID
- S-01
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2007
- Last updated
- 17 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Suzuki H, Kanno Y, Sugahara S, Ikeda N, Shoda J, Takenaka T, Inoue T, Araki R. Effect of angiotensin receptor blockers on cardiovascular events in patients undergoing hemodialysis: an open-label randomized controlled trial. Am J Kidney Dis. 2008 Sep;52(3):501-6. doi: 10.1053/j.ajkd.2008.04.031. Epub 2008 Jul 24.
PubMed 18653268
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Angiotensin Receptor Antagonist on Prohibiting Cardiovascular Events on Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00530595
- Acronym / sponsor ID
- S-01
- Conditions
- Cardiovascular Disease
- Keywords
- hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Saitama Medical UniversityUniversity, hospital or other
- First posted
- 17 Sep 2007 (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.
Cardiovascular disease is a leading cause of mortality in patients on hemodialysis therapy (HD), accounting for 30 to 50% of all death. Although angiotensin receptor blockers (ARBs) are effective for patients with diabetes and chronic kidney disease in reducing or preventing cardiovascular diseases, there has been no decisive study that demonstrated treatment with ARBs is effective in patients on HD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 30 to 80 years of age
- Receiving hemodialysis at least 12 months and less than 5 years
- Pre-dialysis systolic blood pressure was more than 160 mmHg, or more than 150 mmHg if the patients received antihypertensive agents.
Key exclusion criteria (1 listed)
- Use of angiotensin receptor blocker or angiotensin converting enzyme inhibitor
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 |
|---|---|---|
| candesartan or valsartan or losartan | Drug | – |
Primary outcome
Not reported in the source record.
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 17 Sep 2007.
- Derived from this study: PubMed 18653268Suzuki H, Kanno Y, Sugahara S, Ikeda N, Shoda J, Takenaka T, Inoue T, Araki R. Effect of angiotensin receptor blockers on cardiovascular events in patients undergoing hemodialysis: an open-label randomized controlled trial. Am J Kidney Dis. 2008 Sep;52(3):501-6. doi: 10.1053/j.ajkd.2008.04.031. Epub 2008 Jul 24.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Hiromichi Suzuki, MD, PhD study director
Department of Nephrology, Saitama Medical University
Questions about this trial
What is this clinical trial studying?
A study testing candesartan or valsartan or losartan in people with Cardiovascular Disease, run by Saitama Medical University.
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 1 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 17 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00530595, 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 17 Sep 2007.