HypertensionPhase 4NCT00400777
Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in Hypertension
A Phase 4 study testing Valsartan, hydrochlorothiazide and amlodipine in people with Hypertension, run by Novartis at 1 site in Brazil.
Trial summary
This study is designed to evaluate the efficacy and safety of the combination valsartan with hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan with hydrochlorothiazide and remaining uncontrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Valsartan, hydrochlorothiazide and amlodipine
- How many people
- 460 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2006to Jun 2008
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥18 years of age
- Patients treated with up to two high blood pressure medications in a stable dose considered adequate by the investigator, for a minimum of two months, with blood pressure not controlled according to the following criteria:
- Systolic Blood Pressure ≥140 mmHg and/or Diastolic Blood Pressure ≥90 mmHg for low risk patients (no known target organ damage and without risk factor or presenting 1 - except Type 2 diabetes mellitus - risk factor);
- Systolic Blood Pressure ≥130 and/or Diastolic Blood Pressure ≥85 mmHg for medium risk patients (no known target organ damage and 2 or more risk factors - except Type 2 diabetes mellitus);
- Systolic Blood Pressure ≥130 and/or Diastolic Blood Pressure ≥80 mmHg for high risk patients (known target organ damage, and/or Type 2 diabetic patients and/or any clinically identifiable cardiovascular disease). OR
- Systolic Blood Pressure ≥160 mmHg and/or Diastolic Blood Pressure ≥100 mmHg at Visits 1 and 2 for previously untreated patients
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- Patients previously treated but who stopped their medications will be considered untreated after one month without treatment
- Obs: -The target organ are: Brain, Heart, Kidney, Retina.
- The risk factors are: Smoking, Dyslipidemia, Age > 60 years old, and Family history of cardiovascular diseases (women < 65 years old and men < 55 years old
Who cannot join
- Systolic Blood Pressure ≥180 mmHg and/or Diastolic Blood Pressure ≥110 mmHg at Visit 1 or Visit 2
- Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma
- Known Keith-Wagener grade III or IV hypertensive retinopathy
- History of hypertensive encephalopathy
- Cerebrovascular accident or myocardial infarction 12 months prior to Visit 1
- History of transient ischemic attack 12 months prior to Visit 1
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- Percutaneous coronary intervention or coronary artery bypass graft surgery 12 months prior to Visit 1
- Diabetes mellitus type 1
- Diabetes mellitus type 2 under insulin treatment
- Poorly controlled type 2 diabetes mellitus
- History of heart failure Grade II - IV according to the NYHA classification
- Second or third degree heart block without a pacemaker
- Concomitant unstable angina pectoris
- Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
- Clinically significant valvular heart disease
- Women of child-bearing potential
- Pregnant or nursing (lactating) women
- Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period
- Additional protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy of the Combination of Valsartan and Hydrochlorothiazide and Amlodipine in Hypertensive Patients Not Controlled With Valsartan and Hydrochlorothiazide
This study is designed to evaluate the efficacy and safety of the combination valsartan with hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken comparing two different possible ways to achieve the higher dosage of the triple combination, i.e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.
- Conditions
- Hypertension
- Being tested
- Valsartan, hydrochlorothiazide and amlodipine
- Keywords
- Valsartan, hydrochlorothiazide, amlodipine, hypertension, high blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan, hydrochlorothiazide and amlodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching diastolic BP control, Proportion of patients reaching systolic BP control Percentage of diastolic responders,
Secondary outcomes (3)
Mean change from study baseline in Diastolic Blood Pressure and in Systolic Blood Pressure after 4, 8 and 12 weeks of treatment
Mean change from study baseline in standing diastolic and systolic blood pressure after 4, 8 and 12 weeks of treatment
Safety and tolerability of the valsartan/HCTZ/amlodipine treatment algorithm strategy after 4, 8 and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startAug 2006
- Primary completionNov 2007
- Study completionJun 2008
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
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis AG, Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400777
- Sponsor's protocol ID
- CVEA489ABR01
- Status last verified
- Jun 2008
- First submitted
- 15 Nov 2006
- Last updated
- 18 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy of the Combination of Valsartan and Hydrochlorothiazide and Amlodipine in Hypertensive Patients Not Controlled With Valsartan and Hydrochlorothiazide
- ClinicalTrials.gov ID
- NCT00400777
- Acronym / sponsor ID
- CVEA489ABR01
- Conditions
- Hypertension
- Keywords
- Valsartan, hydrochlorothiazide, amlodipine, hypertension, high blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Nov 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.
This study is designed to evaluate the efficacy and safety of the combination valsartan with hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken comparing two different possible ways to achieve the higher dosage of the triple combination, i.e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients ≥18 years of age
- Patients treated with up to two high blood pressure medications in a stable dose considered adequate by the investigator, for a minimum of two months, with blood pressure not controlled according to the following criteria:
- Systolic Blood Pressure ≥140 mmHg and/or Diastolic Blood Pressure ≥90 mmHg for low risk patients (no known target organ damage and without risk factor or presenting 1 - except Type 2 diabetes mellitus - risk factor);
- Systolic Blood Pressure ≥130 and/or Diastolic Blood Pressure ≥85 mmHg for medium risk patients (no known target organ damage and 2 or more risk factors - except Type 2 diabetes mellitus);
- Systolic Blood Pressure ≥130 and/or Diastolic Blood Pressure ≥80 mmHg for high risk patients (known target organ damage, and/or Type 2 diabetic patients and/or any clinically identifiable cardiovascular disease). OR
Key exclusion criteria (19 listed)
- Systolic Blood Pressure ≥180 mmHg and/or Diastolic Blood Pressure ≥110 mmHg at Visit 1 or Visit 2
- Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma
- Known Keith-Wagener grade III or IV hypertensive retinopathy
- History of hypertensive encephalopathy
- Cerebrovascular accident or myocardial infarction 12 months prior to Visit 1
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, hydrochlorothiazide and amlodipine | Drug | – |
Primary outcome
Proportion of patients reaching diastolic BP control, Proportion of patients reaching systolic BP control Percentage of diastolic responders,
3 secondary outcomes
Mean change from study baseline in Diastolic Blood Pressure and in Systolic Blood Pressure after 4, 8 and 12 weeks of treatment
Mean change from study baseline in standing diastolic and systolic blood pressure after 4, 8 and 12 weeks of treatment
Safety and tolerability of the valsartan/HCTZ/amlodipine treatment algorithm strategy after 4, 8 and 12 weeks of treatment
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 18 Jun 2008.
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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 AG study chair
Sponsor GmbH
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, hydrochlorothiazide and amlodipine in people with Hypertension, run by Novartis at 1 site in Brazil.
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 9 inclusion and 19 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 18 Jun 2008. 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 Brazil. 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?
Proportion of patients reaching diastolic BP control, Proportion of patients reaching systolic BP control Percentage of diastolic responders,. 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 18 Jun 2008.