HypertensionPhase 4NCT01004237
Additive Effects of Pravastatin and Valsartan
A Phase 4 study testing pravastatin, valsartan, pravastatin+valsartan in people with Hypertension and High Cholesterol, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hypertension, High Cholesterol
- What is being tested?
- pravastatin, valsartan, pravastatin+valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Apr 2012
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension and low-density lipoprotein cholesterol levels >100
Who cannot join
- Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.
- Conditions
- Hypertension, High Cholesterol
- Being tested
- pravastatin, valsartan, pravastatin+valsartan
- Keywords
- insulin resistance, hypertensive, hypercholesterolemic patients
- Medical subject headings
- Hypertension, Hypercholesterolemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pravastatin, valsartan, pravastatin+valsartanDrug
pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| pravastatin | Active comparator | Not described Receives: Drug: pravastatin, valsartan, pravastatin+valsartan |
| valsartan | Active comparator | Not described Receives: Drug: pravastatin, valsartan, pravastatin+valsartan |
| pravastatin combined with valsartan | Active comparator | Not described Receives: Drug: pravastatin, valsartan, pravastatin+valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow-mediated dilation
Measured: 8 weeks of treatment
Secondary outcomes (1)
insulin resistance
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2012
- Study completionApr 2012
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004237
- Sponsor's protocol ID
- GMC-200912
- Status last verified
- Oct 2010
- First submitted
- 28 Oct 2009
- Last updated
- 9 Aug 2012
- Results posted
- No
Publications
Koh KK, Lim S, Choi H, Lee Y, Han SH, Lee K, Oh PC, Sakuma I, Shin EK, Quon MJ. Combination pravastatin and valsartan treatment has additive beneficial effects to simultaneously improve both metabolic and cardiovascular phenotypes beyond that of monotherapy with either drug in patients with primary hypercholesterolemia. Diabetes. 2013 Oct;62(10):3547-52. doi: 10.2337/db13-0566. Epub 2013 Jul 17.
PubMed 23863812
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effects of Pravastatin and Valsartan
- ClinicalTrials.gov ID
- NCT01004237
- Acronym / sponsor ID
- GMC-200912
- Conditions
- Hypertension, High Cholesterol
- Keywords
- insulin resistance, hypertensive, hypercholesterolemic patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Oct 2009 (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 investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pravastatin | Active comparator | Drug: pravastatin, valsartan, pravastatin+valsartan |
| valsartan | Active comparator | Drug: pravastatin, valsartan, pravastatin+valsartan |
| pravastatin combined with valsartan | Active comparator | Drug: pravastatin, valsartan, pravastatin+valsartan |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypertension and low-density lipoprotein cholesterol levels >100
Key exclusion criteria (1 listed)
- Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
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 |
|---|---|---|
| pravastatin, valsartan, pravastatin+valsartanpravastatin 40 mg, valsartan 160 mg 8 weeks of treatment | Drug | pravastatin, pravastatin combined with valsartan, valsartan |
Primary outcome
flow-mediated dilation
Time frame: 8 weeks of treatment
1 secondary outcome
insulin resistance
Time frame: 8 weeks of treatment
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 9 Aug 2012.
- Derived from this study: PubMed 23863812Koh KK, Lim S, Choi H, Lee Y, Han SH, Lee K, Oh PC, Sakuma I, Shin EK, Quon MJ. Combination pravastatin and valsartan treatment has additive beneficial effects to simultaneously improve both metabolic and cardiovascular phenotypes beyond that of monotherapy with either drug in patients with primary hypercholesterolemia. Diabetes. 2013 Oct;62(10):3547-52. doi: 10.2337/db13-0566. Epub 2013 Jul 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 pravastatin, valsartan, pravastatin+valsartan in people with Hypertension and High Cholesterol, run by Gachon University Gil Medical Center at 1 site in South Korea.
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: finished, as of the sponsor's last update on 9 Aug 2012. 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 South Korea. 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?
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?
flow-mediated dilation (time frame: 8 weeks of treatment). 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 NCT01004237, 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 9 Aug 2012.