Hypertension, PulmonaryPhase 1NCT00538044
Simvatstatin Used to Treat Pulmonary Hypertension
A Phase 1 study testing simvastatin in people with Hypertension, Pulmonary, run by Capital Medical University at 1 site in China.
Trial summary
we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Jan 2009to Jan 2012
- Phase
- Phase 1
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pasp>50mmHg
Who cannot join
- pasp<50mmhg
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital
Beijing, 100029
Huili Gan, MD, Ph.D., 861013001277863, ganhuili@hotamail.com
About this study
Official title: the Clinical Research Using Simvastatin as a Medication to Treat Advanced Secondary Pulmonary Hypertension
we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.
Read the detailed description
advanced pulmonary hypertension is refractory to the medication in use nowaday, especially pulmonary hypertension secondary to congenital heart disease or chronic pulmonary embolism.It is revealed that statins may intefere the pathogenisis of the pulmonary hypertension in many key poing, such as improving apotosis or inhiting the proliferation of pulmonary vascular smooth muscle cell. so we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.
- Conditions
- Hypertension, Pulmonary
- Being tested
- simvastatin
- Keywords
- pulmonary hypertension, simvastatin, advanced pulmonary hypertension secondary to congenital heart disease, advanced pulmonary hypertension secondary to chronic pulmonary embolism
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
medication with simvastation on the dosage of 40mg per day before the operation and all the time after the operation
| Study group | Role | What they receive |
|---|---|---|
| 1simvastatin group | Experimental | before the operation, the patient start the simvastatin medication on the dosage of 40mg per day Receives: Drug: simvastatin |
| 2contral group | No intervention | just do routin operation with no use of simvastatin, other medication is exact the same as the simvastatin group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the simvastatin can alleviate pulmonary hypertension
pulmonary pressure
Secondary outcomes (1)
simvastatin can highten the perioperative and long term survaval rate and the living quality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startJan 2009
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Huili Gan, MD,Ph.D., Study chair, Beijing Anzehn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538044
- Sponsor's protocol ID
- Gan1
- Other IDs
- Anzhen1
- Status last verified
- Sep 2007
- First submitted
- 1 Oct 2007
- Last updated
- 2 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Clinical Research Using Simvastatin as a Medication to Treat Advanced Secondary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00538044
- Acronym / sponsor ID
- Gan1
- Conditions
- Hypertension, Pulmonary
- Keywords
- pulmonary hypertension, simvastatin, advanced pulmonary hypertension secondary to congenital heart disease, advanced pulmonary hypertension secondary to chronic pulmonary embolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Study completion
- Jan 2012 (estimated)
- First posted
- 2 Oct 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.
we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.
Detailed description
advanced pulmonary hypertension is refractory to the medication in use nowaday, especially pulmonary hypertension secondary to congenital heart disease or chronic pulmonary embolism.It is revealed that statins may intefere the pathogenisis of the pulmonary hypertension in many key poing, such as improving apotosis or inhiting the proliferation of pulmonary vascular smooth muscle cell. so we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1simvastatin group | Experimental | Drug: simvastatinbefore the operation, the patient start the simvastatin medication on the dosage of 40mg per day |
| 2contral group | No intervention | –just do routin operation with no use of simvastatin, other medication is exact the same as the simvastatin group |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pasp>50mmHg
Key exclusion criteria (1 listed)
- pasp<50mmhg
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 |
|---|---|---|
| simvastatinmedication with simvastation on the dosage of 40mg per day before the operation and all the time after the operation | Drug | 1simvastatin group |
Primary outcome
the simvastatin can alleviate pulmonary hypertension
pulmonary pressure
1 secondary outcome
simvastatin can highten the perioperative and long term survaval rate and the living quality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2007.
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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.
Huili Gan, MD,Ph.D. study chair
Beijing Anzehn Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing simvastatin in people with Hypertension, Pulmonary, run by Capital Medical University 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 1 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: status not confirmed, as of the sponsor's last update on 2 Oct 2007. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Huili Gan, MD,Ph.D. (13001277863, ganhuili@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the simvastatin can alleviate pulmonary hypertension. The study lists 2 primary outcomes in all. 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 2 Oct 2007.