HypertensionPhase 4NCT00351130
Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy
A Phase 4 study testing valsartan and amlodipine in people with Hypertension, run by Novartis at 2 sites in 2 countries.
Trial summary
Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan and amlodipine
- How many people
- 79 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2006to Mar 2007
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- MSSBP> 140 mm Hg, and/or MSDBP> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study
Who cannot join
- Premature discontinuation in the core study or failure to comply with the core study protocol
- Any patient that the investigator decides should not participate in the extension
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An 8 Week Extension to a Randomized, Double-blind, Parallel Group, Active-controlled, Multi-center, 14 Week Study to Evaluate the Effectiveness of a Valsartan Versus and Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy
Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.
- Conditions
- Hypertension
- Being tested
- valsartan, amlodipine
- Keywords
- Hypertension,, stage 1 hypertension,, stage 2 hypertension,, valsartan,, amlodipine,
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
amlodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks
Secondary outcomes (2)
Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks
Adverse events after 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2007
- Study completionMar 2007
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
- Double blind
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novatis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351130
- Sponsor's protocol ID
- CVAH631B2406E1
- Status last verified
- Feb 2017
- First submitted
- 16 Mar 2006
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8 Week Extension to a Randomized, Double-blind, Parallel Group, Active-controlled, Multi-center, 14 Week Study to Evaluate the Effectiveness of a Valsartan Versus and Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy
- ClinicalTrials.gov ID
- NCT00351130
- Acronym / sponsor ID
- CVAH631B2406E1
- Conditions
- Hypertension
- Keywords
- Hypertension,, stage 1 hypertension,, stage 2 hypertension,, valsartan,, amlodipine,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 12 Jul 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.
Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.
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 (1 listed)
- MSSBP> 140 mm Hg, and/or MSDBP> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study
Key exclusion criteria (3 listed)
- Premature discontinuation in the core study or failure to comply with the core study protocol
- Any patient that the investigator decides should not participate in the extension
- Other protocol-defined inclusion/exclusion criteria may apply
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 | – |
| amlodipine | Drug | – |
Primary outcome
Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks
2 secondary outcomes
Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks
Adverse events after 22 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 24 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
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 4 study testing valsartan and amlodipine in people with Hypertension, 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 1 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 24 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 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 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?
Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 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 24 Feb 2017.