HypertensionPhase 4NCT00333489
Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
A Phase 4 study testing valsartan in people with Hypertension, run by Novartis at 1 site in Switzerland.
Trial summary
The objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipine alone. Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO classification (8)]. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan
- How many people
- 551 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2004to Apr 2005
- 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 21 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Severe hypertension (grade 3 of WHO classification: DBP >= 110 mmHg and/or SBP ≥ 180 mmHg) or malignant hypertension.
- Inability to completely discontinue all antihypertensive medications safely for a period of at least 2 weeks as required by the protocol.
- Evidence of a secondary form of hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A National, Multicentric and Comparative Study to Evaluate Efficacy and Tolerability of the Association of Valsartan and Amlodipine Versus Amlodipine Alone in the Treatment of Essential Arterial Hypertension - Stages I and II (Mild to Moderate).
The objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipine alone.
Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO classification (8)]. The diastolic blood pressure threshold for inclusion in this study is 95 mmHg, as these patients are more likely to benefit from association therapy than patients with lower diastolic blood pressure.
For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will not be included in this study. Moreover, patients developing severe hypertension (MSDBP > 110 mmHg and/or MSSBP > 180 mmHg) during the open-label treatment phase will be discontinued from the study.
- Conditions
- Hypertension
- Being tested
- valsartan
- Keywords
- valsartan, amlodipine, hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
Secondary outcomes (3)
Change from baseline in the mean sitting systolic blood pressure from baseline after 8 weeks
Adverse events after 8 weeks
Change from baseline in standing blood pressure and heart rate after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startMar 2004
- Primary completionApr 2005
- Study completionApr 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333489
- Sponsor's protocol ID
- CVAL489ABR02
- Status last verified
- Jun 2006
- First submitted
- 1 Jun 2006
- Last updated
- 8 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Multicentric and Comparative Study to Evaluate Efficacy and Tolerability of the Association of Valsartan and Amlodipine Versus Amlodipine Alone in the Treatment of Essential Arterial Hypertension - Stages I and II (Mild to Moderate).
- ClinicalTrials.gov ID
- NCT00333489
- Acronym / sponsor ID
- CVAL489ABR02
- Conditions
- Hypertension
- Keywords
- valsartan, amlodipine, hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 5 Jun 2006 (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 objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipine alone.
Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO classification (8)]. The diastolic blood pressure threshold for inclusion in this study is 95 mmHg, as these patients are more likely to benefit from association therapy than patients with lower diastolic blood pressure.
For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will not be included in this study. Moreover, patients developing severe hypertension (MSDBP > 110 mmHg and/or MSSBP > 180 mmHg) during the open-label treatment phase will be discontinued from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Severe hypertension (grade 3 of WHO classification: DBP >= 110 mmHg and/or SBP ≥ 180 mmHg) or malignant hypertension.
- Inability to completely discontinue all antihypertensive medications safely for a period of at least 2 weeks as required by the protocol.
- Evidence of a secondary form of hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
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 | Drug | – |
Primary outcome
Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
3 secondary outcomes
Change from baseline in the mean sitting systolic blood pressure from baseline after 8 weeks
Adverse events after 8 weeks
Change from baseline in standing blood pressure and heart rate after 8 weeks
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 8 Nov 2011.
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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 chair
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 4 study testing valsartan in people with Hypertension, run by Novartis at 1 site in Switzerland.
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 0 inclusion and 3 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 8 Nov 2011. 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 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 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?
Change from baseline in the mean sitting diastolic blood pressure after 8 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 8 Nov 2011.