Type 2 Diabetes MellitusNCT00655330
Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy
A study testing Valsartan and Probucol in people with Type 2 Diabetes Mellitus and Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction of urinary albumin or proteinuria will be the primary outcome studied. The expected study duration will be 48 weeks. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Nephropathy
- What is being tested?
- Valsartan and Probucol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- May 2008to May 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes nephropathy
- Urinary albumin excretion 1-3g/24hours
- Serum creatinine < 3mg/dl
Who cannot join
- Type 1 diabetes mellitus
- Renal diseases other than type 2 Diabetes nephropathy
- Renal artery stenosis
- Severe heart diseases
- Tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy
This is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction of urinary albumin or proteinuria will be the primary outcome studied. The expected study duration will be 48 weeks.
Read the detailed description
a prospective randomized controlled, open-labeled study in patients with Diabetes nephropathy
- Arm 1: Valsartan + Probucol Valsartan (160mg/day) + Probucol (750mg/day)
- Arm 2: Valsartan + Placebo Valsartan (160mg/day) + Placebo
- Conditions
- Type 2 Diabetes Mellitus, Nephropathy
- Being tested
- Valsartan, Placebo, Probucol
- Keywords
- Type 2 diabetes mellitus, Nephropathy, valsartan, probucol, Proteinuria
- Medical subject headings
- Diabetes Mellitus, Type 2, Kidney Diseases, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Valsartan (160mg/day)
PlaceboDrug
Placebo
ProbucolDrug
Probucol (750mg/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Valsartan (160mg/day)is given in combination with Placebo Receives: Drug: Valsartan; Drug: Placebo |
| 2 | Experimental | Valsartan (160mg/day) + Probucol (750mg/day) Receives: Drug: Valsartan; Drug: Probucol |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary albumin excretion or proteinuria at week 48
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Shi, Guangdong Provincial People's Hospital
- Investigators
- Shi Wei, MD, PhD, Principal investigator, Nephrology Dept.,Guangdong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655330
- Sponsor's protocol ID
- GPPH200603 -1
- Status last verified
- Aug 2016
- First submitted
- 2 Apr 2008
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Controlled, Open-labeled Trial of Probucol Combined With Valsartan in Patients With Diabetes Nephropathy
- ClinicalTrials.gov ID
- NCT00655330
- Acronym / sponsor ID
- GPPH200603 -1
- Conditions
- Type 2 Diabetes Mellitus, Nephropathy
- Keywords
- Type 2 diabetes mellitus, Nephropathy, valsartan, probucol, Proteinuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 9 Apr 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.
This is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction of urinary albumin or proteinuria will be the primary outcome studied. The expected study duration will be 48 weeks.
Detailed description
a prospective randomized controlled, open-labeled study in patients with Diabetes nephropathy
- Arm 1: Valsartan + Probucol Valsartan (160mg/day) + Probucol (750mg/day)
- Arm 2: Valsartan + Placebo Valsartan (160mg/day) + Placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Valsartan, Drug: PlaceboValsartan (160mg/day)is given in combination with Placebo |
| 2 | Experimental | Drug: Valsartan, Drug: ProbucolValsartan (160mg/day) + Probucol (750mg/day) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes nephropathy
- Urinary albumin excretion 1-3g/24hours
- Serum creatinine < 3mg/dl
Key exclusion criteria (5 listed)
- Type 1 diabetes mellitus
- Renal diseases other than type 2 Diabetes nephropathy
- Renal artery stenosis
- Severe heart diseases
- Tuberculosis
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 (160mg/day) | Drug | 1, 2 |
| PlaceboPlacebo | Drug | 1 |
| ProbucolProbucol (750mg/day) | Drug | 2 |
Primary outcome
urinary albumin excretion or proteinuria at week 48
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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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.
Shi Wei, MD, PhD principal investigator
Nephrology Dept.,Guangdong General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valsartan and Probucol in people with Type 2 Diabetes Mellitus and Nephropathy, run by Guangdong Provincial People's Hospital 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 3 inclusion and 5 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 24 Aug 2016. 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. 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?
Results are not available in the source record.
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?
urinary albumin excretion or proteinuria at week 48 (time frame: 48 weeks). 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 24 Aug 2016.