HypertensionPhase 3NCT00327145
A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy
A Phase 3 study testing valsartan, hydrochlorothiazide and amlodipine in people with Hypertension, run by Novartis at 1 site in Switzerland.
Trial summary
This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 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
- 894 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2006to Jan 2007
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female patients ≥18 years of age
- Non-diabetic patients must have MSSBP of ≥140 mmHg and/or MSDBP ≥90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP ≥130 mmHg and/or MSDBP ≥80 mmHg at Visits 1 and 2
- Patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to Visit 1
Who cannot join
- Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure.
- MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg (MSSBP ≥160 mmHg and/or MSDBP ≥100 mmHg for diabetic patients) at any time between Visit 1 and 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.
- Other exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Multicenter Study to Evaluate the Effectiveness of the Combination of Valsartan & Amlodipine in Hypertensive Patients Not Controlled on Monotherapy
This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ
- Conditions
- Hypertension
- Being tested
- valsartan, hydrochlorothiazide, amlodipine
- Keywords
- HCTZ, 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
hydrochlorothiazideDrug
amlodipineDrug
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 blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks
Secondary outcomes (4)
Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 8 weeks.
Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 4, 12, and 16 weeks.
Change from baseline diastolic and systolic blood pressure measurements after 4, 8, 12, and 16 weeks
Diastolic blood pressure less than 90 mmHg in non-diabetic patients and diastolic blood pressure less than 80 mmHg in diabetic patients after 4, 8, 12, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 894 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
- NCT00327145
- Sponsor's protocol ID
- CVAA489A2401
- Status last verified
- Nov 2016
- First submitted
- 16 May 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Allemann Y, Fraile B, Lambert M, Barbier M, Ferber P, Izzo JL Jr. Efficacy of the combination of amlodipine and valsartan in patients with hypertension uncontrolled with previous monotherapy: the Exforge in Failure after Single Therapy (EX-FAST) study. J Clin Hypertens (Greenwich). 2008 Mar;10(3):185-94. doi: 10.1111/j.1751-7176.2008.07516.x.
PubMed 18326958
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multicenter Study to Evaluate the Effectiveness of the Combination of Valsartan & Amlodipine in Hypertensive Patients Not Controlled on Monotherapy
- ClinicalTrials.gov ID
- NCT00327145
- Acronym / sponsor ID
- CVAA489A2401
- Conditions
- Hypertension
- Keywords
- HCTZ, hypertension, valsartan, amlodipine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 894 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 18 May 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 provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients ≥18 years of age
- Non-diabetic patients must have MSSBP of ≥140 mmHg and/or MSDBP ≥90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP ≥130 mmHg and/or MSDBP ≥80 mmHg at Visits 1 and 2
- Patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to Visit 1
Key exclusion criteria (5 listed)
- Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure.
- MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg (MSSBP ≥160 mmHg and/or MSDBP ≥100 mmHg for diabetic patients) at any time between Visit 1 and 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.
- Other exclusion criteria 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 | – |
| hydrochlorothiazide | Drug | – |
| amlodipine | Drug | – |
Primary outcome
Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks
4 secondary outcomes
Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 8 weeks.
Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 4, 12, and 16 weeks.
Change from baseline diastolic and systolic blood pressure measurements after 4, 8, 12, and 16 weeks
Diastolic blood pressure less than 90 mmHg in non-diabetic patients and diastolic blood pressure less than 80 mmHg in diabetic patients after 4, 8, 12, and 16 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 18 Nov 2016.
- Results publication: PubMed 18326958Allemann Y, Fraile B, Lambert M, Barbier M, Ferber P, Izzo JL Jr. Efficacy of the combination of amlodipine and valsartan in patients with hypertension uncontrolled with previous monotherapy: the Exforge in Failure after Single Therapy (EX-FAST) study. J Clin Hypertens (Greenwich). 2008 Mar;10(3):185-94. doi: 10.1111/j.1751-7176.2008.07516.x.
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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 3 study testing valsartan, hydrochlorothiazide and amlodipine 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 3 inclusion and 5 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 Nov 2016. 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 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?
Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00327145, which also lists 1 linked publication.
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 Nov 2016.