HYPERTENSIONPhase 3NCT00171093
A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia
A Phase 3 study testing valsartan + simvastatin in people with HYPERTENSION and HYPERCHOLESTEROLEMIA, run by Novartis at 1 site in United States.
Trial summary
This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HYPERTENSION, HYPERCHOLESTEROLEMIA
- What is being tested?
- valsartan + simvastatin
- How many people
- 369 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jan 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 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- ESSENTIAL HYPERTENSION
- ELEVATED LDL-C CHOLESTEROL
- USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS
Who cannot join
- SEVERE HYPERTENSION
- EVIDENCE OF HISTORY OR CURRENT HEART DISEASE
- HISTORY OF STROKE OR MYOCARDIAL INFARCTION
- DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES
- UNCONTROLLED DIABETES OR INSULIN
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: A 10-12 Week Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of the Combination of Valsartan (320 mg) and Simvastatin (80 mg) Compared to Valsartan (320 mg) and Simvastatin (80 mg) Monotherapies in Essential Hypertension and Hypercholesterolemia
This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..
- Conditions
- HYPERTENSION, HYPERCHOLESTEROLEMIA
- Being tested
- valsartan + simvastatin
- Keywords
- HYPERTENSION, HYPERCHOLESTEROLEMIA, BLOOD PRESSURE, CHOLESTEROL, VALSARTAN, SIMVASTATIN
- Medical subject headings
- Hypertension, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartan + simvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average ambulatory systolic blood pressure over 24 hours
Change in serum low density lipoprotein cholesterol (LDL-C )
Secondary outcomes (5)
Adverse events and serious adverse events at each study visit for 42 days
Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies
Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime
Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication
Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 369 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171093
- Sponsor's protocol ID
- CVAS489A2316
- Status last verified
- Feb 2017
- First submitted
- 10 Sep 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 10-12 Week Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of the Combination of Valsartan (320 mg) and Simvastatin (80 mg) Compared to Valsartan (320 mg) and Simvastatin (80 mg) Monotherapies in Essential Hypertension and Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00171093
- Acronym / sponsor ID
- CVAS489A2316
- Conditions
- HYPERTENSION, HYPERCHOLESTEROLEMIA
- Keywords
- HYPERTENSION, HYPERCHOLESTEROLEMIA, BLOOD PRESSURE, CHOLESTEROL, VALSARTAN, SIMVASTATIN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jan 2006 (actual)
- First posted
- 15 Sep 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.
This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ESSENTIAL HYPERTENSION
- ELEVATED LDL-C CHOLESTEROL
- USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS
Key exclusion criteria (6 listed)
- SEVERE HYPERTENSION
- EVIDENCE OF HISTORY OR CURRENT HEART DISEASE
- HISTORY OF STROKE OR MYOCARDIAL INFARCTION
- DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES
- UNCONTROLLED DIABETES OR INSULIN
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 |
|---|---|---|
| valsartan + simvastatin | Drug | – |
Primary outcome
Change in average ambulatory systolic blood pressure over 24 hours
Change in serum low density lipoprotein cholesterol (LDL-C )
5 secondary outcomes
Adverse events and serious adverse events at each study visit for 42 days
Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies
Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime
Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication
Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days
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 23 Feb 2017.
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing valsartan + simvastatin in people with HYPERTENSION and HYPERCHOLESTEROLEMIA, run by Novartis at 1 site in United States.
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 6 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 23 Feb 2017. 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 United States. 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?
Change in average ambulatory systolic blood pressure over 24 hours. 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 23 Feb 2017; AzTrials last refreshed its copy on 1 Nov 2026.