Essential HypertensionPhase 3NCT00254475
A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia
A Phase 3 study testing simvastatin and valsartan in people with Essential Hypertension and Hypercholesterolemia, run by Novartis at 2 sites in 2 countries.
Trial summary
The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension, Hypercholesterolemia
- What is being tested?
- simvastatin and valsartan
- How many people
- 871 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2005to Sep 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Elevated LDL-Cholesterol
- Essential hypertension
Who cannot join
- Severe Hypertension
- Prior or known muscular or neuromuscular disease of any type
- A history of cardiovascular disease
- Hypertension or hypercholesterolemia due to secondary causes
- Uncontrolled diabetes or insulin treatment
- Evidence of hepatic or renal disease
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Study to Evaluate the Efficacy of the Valsartan/Simvastatin Combinations 160/20mg up Titrated to 320/20mg Versus 160/40mg up Titrated to 320/40mg in Patients With Both Essential Hypertension and Hypercholesterolemia
The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.
- Conditions
- Essential Hypertension, Hypercholesterolemia
- Being tested
- simvastatin, valsartan
- Keywords
- Valsartan, simvastatin, hypertension, hypercholesterolemia, angiotensin II receptor blocker
- Medical subject headings
- Essential Hypertension, Hypercholesterolemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
valsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoproteins after 6 weeks
Secondary outcomes (5)
Lipid profile at 6, 12 wks
BP < 140/90 mmHg in non diabetics, or < 130/80 mmHg in diabetics, and LDL-C < 2.6, 3.4 or 4.1 mmol/l based on risk group at 6, 12 wks
SBP < 140 mmHg in non diabetics, < 130 mmHg in diabetics, or 20 mmHg decrease in SBP from baseline and DBP < 90 mmHg in non diabetics, DBP < 80 mmHg in diabetics, or 10 mmHg decrease in DBP from baseline at 6, 12 wks
Systolic and diastolic bp at 6, 12 wks
Serious/adverse events, labs, physical exams, vitals up to 12 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionSep 2006
- Study completionSep 2006
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 Essential 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceutical, Study director, Novatis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254475
- Sponsor's protocol ID
- CVAS489A2403
- Status last verified
- Aug 2014
- First submitted
- 7 Nov 2005
- Last updated
- 19 Aug 2014
- Results posted
- No
Publications
Rump LC, Baranova E, Okopien B, Weisskopf M, Kandra A, Ferber P. Coadministration of valsartan 160 and 320 mg and simvastatin 20 and 40 mg in patients with hypertension and hypercholesterolemia: a multicenter, 12-week, double-blind, double-dummy, parallel-group superiority study. Clin Ther. 2008 Oct;30(10):1782-93. doi: 10.1016/j.clinthera.2008.10.004.
PubMed 19014834
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of the Valsartan/Simvastatin Combinations 160/20mg up Titrated to 320/20mg Versus 160/40mg up Titrated to 320/40mg in Patients With Both Essential Hypertension and Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00254475
- Acronym / sponsor ID
- CVAS489A2403
- Conditions
- Essential Hypertension, Hypercholesterolemia
- Keywords
- Valsartan, simvastatin, hypertension, hypercholesterolemia, angiotensin II receptor blocker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 16 Nov 2005 (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 provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elevated LDL-Cholesterol
- Essential hypertension
Key exclusion criteria (7 listed)
- Severe Hypertension
- Prior or known muscular or neuromuscular disease of any type
- A history of cardiovascular disease
- Hypertension or hypercholesterolemia due to secondary causes
- Uncontrolled diabetes or insulin treatment
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 |
|---|---|---|
| simvastatin | Drug | – |
| valsartan | Drug | – |
Primary outcome
Low density lipoproteins after 6 weeks
5 secondary outcomes
Lipid profile at 6, 12 wks
BP < 140/90 mmHg in non diabetics, or < 130/80 mmHg in diabetics, and LDL-C < 2.6, 3.4 or 4.1 mmol/l based on risk group at 6, 12 wks
SBP < 140 mmHg in non diabetics, < 130 mmHg in diabetics, or 20 mmHg decrease in SBP from baseline and DBP < 90 mmHg in non diabetics, DBP < 80 mmHg in diabetics, or 10 mmHg decrease in DBP from baseline at 6, 12 wks
Systolic and diastolic bp at 6, 12 wks
Serious/adverse events, labs, physical exams, vitals up to 12 wks
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 19 Aug 2014.
- Derived from this study: PubMed 19014834Rump LC, Baranova E, Okopien B, Weisskopf M, Kandra A, Ferber P. Coadministration of valsartan 160 and 320 mg and simvastatin 20 and 40 mg in patients with hypertension and hypercholesterolemia: a multicenter, 12-week, double-blind, double-dummy, parallel-group superiority study. Clin Ther. 2008 Oct;30(10):1782-93. doi: 10.1016/j.clinthera.2008.10.004.
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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.
Novartis Pharmaceutical study director
Novatis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing simvastatin and valsartan in people with Essential Hypertension and Hypercholesterolemia, run by Novartis at 2 sites in 2 countries.
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 2 inclusion and 7 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 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Low density lipoproteins after 6 weeks. 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 NCT00254475, 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 19 Aug 2014.