Chronic Kidney DiseasePhase 4AHOCEPNCT01351636
Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients
A Phase 4 study testing Arotinolol Hydrochloride and Non arotinolol group in people with Chronic Kidney Disease, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Arotinolol Hydrochloride and Non arotinolol group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to 10 Oct 2018
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-75 years-old;
- Chronic kidney disease stage 5 with haemodialysis treatment for 2 months;
- Patients with blood pressure≥140/90 mmHg after receiving 2 or 3 antihypertensive medications for 2 weeks;
- Patients who receiving alfa or beta blockers will be washed out for 2 weeks;
- Written informed consent
Who cannot join
- Unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months;
- Patients who taking class I antiarrhythmic drugs;
- Resting heart rate less than 60;
- Patients with systolic pressure less than 90 mmHg;
- Patients with chronic obstructive pulmonary disease and asthma;
- Patients with cerebral infarction in the last 2 weeks;
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- Severe disorders of liver function;
- Allergy to the arotinolol;
- Patients who planning to have kidney transplantation in the near future;
- Pregnancy and breast-feeding;
- Malignant tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial
The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.
- Conditions
- Chronic Kidney Disease
- Being tested
- Arotinolol Hydrochloride, Non arotinolol group
- Keywords
- chronic kidney disease, hypertension
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arotinolol HydrochlorideDrug
Also called Almarl
Antihypertensive medications plus arotinolol hydrochloride, dosage of arotinolol hydrochloride from 2.5mg bid, 2 days later increased to 5mg bid or 10mg bid, for 18 months
Non arotinolol groupDrug
Also called Control group
Antihypertensive medications without arotinolol for 18 months
| Study group | Role | What they receive |
|---|---|---|
| Arotinolol Hydrochloride | Experimental | Antihypertensive medications plus arotinolol hydrochloride Receives: Drug: Arotinolol Hydrochloride |
| Non arotinolol group | Placebo comparator | Antihypertensive medications without arotinolol hydrochloride Receives: Drug: Non arotinolol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoints
Measured: 18 months
Secondary outcomes (2)
Changes for metabolism related index
Measured: 18 months
Blood pressure control in hypertensive haemodialysis patients
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startApr 2011
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nan Chen, PhD, MD, Principal investigator, Shanghai Jiaotong University Medical School Affiliated Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351636
- Sponsor's protocol ID
- DSPC-ALM-1101
- Acronym
- AHOCEP
- Status last verified
- Nov 2015
- First submitted
- 5 May 2011
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial
- ClinicalTrials.gov ID
- NCT01351636
- Acronym / sponsor ID
- AHOCEP / DSPC-ALM-1101
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2011 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 11 May 2011 (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 ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arotinolol Hydrochloride | Experimental | Drug: Arotinolol HydrochlorideAntihypertensive medications plus arotinolol hydrochloride |
| Non arotinolol group | Placebo comparator | Drug: Non arotinolol groupAntihypertensive medications without arotinolol hydrochloride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18-75 years-old;
- Chronic kidney disease stage 5 with haemodialysis treatment for 2 months;
- Patients with blood pressure≥140/90 mmHg after receiving 2 or 3 antihypertensive medications for 2 weeks;
- Patients who receiving alfa or beta blockers will be washed out for 2 weeks;
- Written informed consent
Key exclusion criteria (11 listed)
- Unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months;
- Patients who taking class I antiarrhythmic drugs;
- Resting heart rate less than 60;
- Patients with systolic pressure less than 90 mmHg;
- Patients with chronic obstructive pulmonary disease and asthma;
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 |
|---|---|---|
| Arotinolol HydrochlorideAlso: AlmarlAntihypertensive medications plus arotinolol hydrochloride, dosage of arotinolol hydrochloride from 2.5mg bid, 2 days later increased to 5mg bid or 10mg bid, for 18 months | Drug | Arotinolol Hydrochloride |
| Non arotinolol groupAlso: Control groupAntihypertensive medications without arotinolol for 18 months | Drug | Non arotinolol group |
Primary outcome
Composite endpoints
Time frame: 18 months
2 secondary outcomes
Changes for metabolism related index
Time frame: 18 months
Blood pressure control in hypertensive haemodialysis patients
Time frame: 18 months
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 Apr 2019.
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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.
Nan Chen, PhD, MD principal investigator
Shanghai Jiaotong University Medical School Affiliated Ruijin Hospital
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 Arotinolol Hydrochloride and Non arotinolol group in people with Chronic Kidney Disease, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
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 5 inclusion and 11 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 Apr 2019. 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 China. 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. Some participants in this study may receive a placebo. 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 endpoints (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2019.