HypertensionPhase 3NCT00409643
Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients
A Phase 3 study testing valsartan+amlodipine combination, valsartan and amlodipine in people with Hypertension, run by Novartis at 2 sites in 2 countries.
Trial summary
This trial will compare valsartan and amlodipine combination therapies to valsartan and amlodipine monotherapy,and placebo for treating patients with hypertension 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+amlodipine combination, valsartan and amlodipine
- How many people
- 1,259 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2004to Jul 2004
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients 18 years and older.
- Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use is disallowed.
- Patients with essential diastolic hypertension measured by calibrated standard aneroid or mercury (preferable) sphygmomanometer. Patients must have a MSDBP > 90 mmHg and < 110 mmHg at Visit 1 (week -4 to -2), and a MSDBP > 95 mmHg and < 110 mmHg at Visit 2 (week 0).
- Patients must have an absolute difference of > 10 mmHg in their average sitting diastolic blood pressure between Visits 1 and 2.
- Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
Who cannot join
- Severe hypertension (MSDBP 110 mmHg and/or MSSBP 180 mmHg) at anytime.
- Inability to discontinue all prior antihypertensive medications safely for a period of 14 weeks.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 0 (week -6 to -4).
- Transient ischemic cerebral attack during the last 12 months prior to Visit 0 (week -6 to -4).
- Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing Disease, pheochromocytoma, polycystic kidney disease etc.
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- Type 1 diabetes mellitus.
- Type 2 diabetes mellitus with poor glucose control as defined by fasting glycosylated hemoglobin (HbA1c) >8% at Visit 1 (week -4 to -2).
- Administration of any agent indicated for the treatment of hypertension within a minimum 4 weeks prior to randomization into the study (Visit 2, week 0), with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 0 (week -6 to -4).
- Known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: A Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients
This trial will compare valsartan and amlodipine combination therapies to valsartan and amlodipine monotherapy,and placebo for treating patients with hypertension
- Conditions
- Hypertension
- Being tested
- valsartan+amlodipine combination, valsartan, amlodipine
- Keywords
- HYPERTENSION, VALSARTAN, AMLODIPINE, 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+amlodipine combinationDrug
valsartanDrug
amlodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (endpoint-Week 8).
Secondary outcomes (3)
Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (endpoint-Wk 8)
Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(endpoint-Wk 8)
Sitting and standing pulse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
- Study startJan 2004
- Primary completionJul 2004
- Study completionJul 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis pharmaceuticals, Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409643
- Sponsor's protocol ID
- CVAA489A2307
- Status last verified
- Nov 2011
- First submitted
- 7 Dec 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 Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00409643
- Acronym / sponsor ID
- CVAA489A2307
- Conditions
- Hypertension
- Keywords
- HYPERTENSION, VALSARTAN, AMLODIPINE, high blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,259 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 11 Dec 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 trial will compare valsartan and amlodipine combination therapies to valsartan and amlodipine monotherapy,and placebo for treating patients with hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients 18 years and older.
- Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use is disallowed.
- Patients with essential diastolic hypertension measured by calibrated standard aneroid or mercury (preferable) sphygmomanometer. Patients must have a MSDBP > 90 mmHg and < 110 mmHg at Visit 1 (week -4 to -2), and a MSDBP > 95 mmHg and < 110 mmHg at Visit 2 (week 0).
- Patients must have an absolute difference of > 10 mmHg in their average sitting diastolic blood pressure between Visits 1 and 2.
- Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
Key exclusion criteria (11 listed)
- Severe hypertension (MSDBP 110 mmHg and/or MSSBP 180 mmHg) at anytime.
- Inability to discontinue all prior antihypertensive medications safely for a period of 14 weeks.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 0 (week -6 to -4).
- Transient ischemic cerebral attack during the last 12 months prior to Visit 0 (week -6 to -4).
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+amlodipine combination | Drug | – |
| valsartan | Drug | – |
| amlodipine | Drug | – |
Primary outcome
Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (endpoint-Week 8).
3 secondary outcomes
Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (endpoint-Wk 8)
Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(endpoint-Wk 8)
Sitting and standing pulse
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
Sponsor GmbH
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing valsartan+amlodipine combination, 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 5 inclusion and 11 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 2 sites in United States, Germany. 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?
Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (endpoint-Week 8).. 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.