HypertensionPhase 4NCT00171444
Comparison of Two Treatment Strategies in Hypertensive Patients
A Phase 4 study testing Medical education in people with Hypertension, run by Novartis.
Trial summary
The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood pressure in their patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Medical education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,445 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to May 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- • Male or female patients >18 years of age
- Hypertension defined by MSDBP ≥ 90 and /or MSSBP ≥ 140 mmHg for untreated patients, patients on diet and exercise, patients on current anti-hypertensive monotherapy or bitherapy treatment who remain uncontrolled or patients experiencing unacceptable side-effects,
Who cannot join
- • Severe hypertension, secondary hypertension, type 1 diabetes mellitus
- History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A 8-week Comparison, in a General Practice Setting, Between Two Treatment Strategies With Valsartan and Valsartan/HCTZ Aiming at Normalizing de Novo Hypertensive Patients Who Are Not Adequately Controlled With Their Monotherapy or Biotherapy Treatment or Experiencing Unacceptable Side-effects, According to Their Baseline Blood Pressure
The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood pressure in their patient population.
- Conditions
- Hypertension
- Being tested
- Medical education
- Keywords
- hypertension,, valsartan+hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical educationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure less than 140/90 mmHg in non-diabetic patients, or less than 130/80 mmHg in patients with diabetes or kidney disease, after 8 weeks
Secondary outcomes (4)
Change from baseline systolic blood pressure after 8 weeks
Change from baseline diastolic blood pressure after 8 weeks
Diastolic blood pressure less than 90 mmHg or reduction in diastolic blood pressure greater than 10 mmHg
Systolic blood pressure less than 140 mmHg or reduction in diastolic blood pressure greater than 15 mmHg
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 startJun 2004
- Primary completionMay 2005
- Study completionMay 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,445 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
- NCT00171444
- Sponsor's protocol ID
- CVAH631DFR06
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- 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 8-week Comparison, in a General Practice Setting, Between Two Treatment Strategies With Valsartan and Valsartan/HCTZ Aiming at Normalizing de Novo Hypertensive Patients Who Are Not Adequately Controlled With Their Monotherapy or Biotherapy Treatment or Experiencing Unacceptable Side-effects, According to Their Baseline Blood Pressure
- ClinicalTrials.gov ID
- NCT00171444
- Acronym / sponsor ID
- CVAH631DFR06
- Conditions
- Hypertension
- Keywords
- hypertension,, valsartan+hydrochlorothiazide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,445 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (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.
The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood pressure in their patient population.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Male or female patients >18 years of age
Key exclusion criteria (3 listed)
- • Severe hypertension, secondary hypertension, type 1 diabetes mellitus
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 |
|---|---|---|
| Medical education | Behavioural | – |
Primary outcome
Blood pressure less than 140/90 mmHg in non-diabetic patients, or less than 130/80 mmHg in patients with diabetes or kidney disease, after 8 weeks
4 secondary outcomes
Change from baseline systolic blood pressure after 8 weeks
Change from baseline diastolic blood pressure after 8 weeks
Diastolic blood pressure less than 90 mmHg or reduction in diastolic blood pressure greater than 10 mmHg
Systolic blood pressure less than 140 mmHg or reduction in diastolic blood pressure greater than 15 mmHg
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 director
Novatis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medical education in people with Hypertension, run by Novartis.
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 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.
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?
Blood pressure less than 140/90 mmHg in non-diabetic patients, or less than 130/80 mmHg in patients with diabetes or kidney disease, 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.