HypertensionPhase 3NCT00409760
Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension.
A Phase 3 study testing valsartan+amlodipine combination, valsartan, amlodipine in people with Hypertension, run by Novartis at 1 site in Germany.
Trial summary
This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of 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, amlodipine
- How many people
- 1,930 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Feb 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 mild to moderate essential diastolic hypertension (grades 1 and 2 WHO classification) measured by calibrated standard sphygmomanometer.
- Patients must have a MSDBP >= 90 mmHg and < 110 mmHg at Visit 1 (week -2 to -4), 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 (grade 3 WHO classification; MSDBP >=110 mmHg diastolic and/or MSSBP >= 180 mmHg systolic).
- Inability to discontinue all prior anti-hypertensive 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 1 (week -2 to -4).
- Transient ischemic cerebral attack during the last 12 months prior to Visit 1 (week -2 to -4).
- Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis, or pheochromocytoma, 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 -2 to -4).
- 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 -4 to -6).
- 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
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients.
This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of hypertension.
- Conditions
- Hypertension
- Being tested
- valsartan+amlodipine combination, valsartan, amlodipine
- Keywords
- HYEPRTENSION, 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 combination, valsartan, 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 (Wk 4 and Wk 8)
Secondary outcomes (3)
Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (Wk 4 and Wk 8)
Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(Wk 4 and 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 2003
- Primary completionFeb 2004
- Study completionFeb 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
- 1,930 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
- NCT00409760
- Sponsor's protocol ID
- CVAA489A2201
- Status last verified
- Oct 2023
- First submitted
- 7 Dec 2006
- Last updated
- 12 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. 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 and Amlodipine Combined and Alone in Hypertensive Patients.
- ClinicalTrials.gov ID
- NCT00409760
- Acronym / sponsor ID
- CVAA489A2201
- Conditions
- Hypertension
- Keywords
- HYEPRTENSION, VALSARTAN, AMLODIPINE, high blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,930 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 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 both valsartan and amlodipine, and placebo for the treatment of 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 (7 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 mild to moderate essential diastolic hypertension (grades 1 and 2 WHO classification) measured by calibrated standard sphygmomanometer.
- Patients must have a MSDBP >= 90 mmHg and < 110 mmHg at Visit 1 (week -2 to -4), and a MSDBP >= 95 mmHg and < 110 mmHg at Visit 2 (week 0).
Key exclusion criteria (11 listed)
- Severe hypertension (grade 3 WHO classification; MSDBP >=110 mmHg diastolic and/or MSSBP >= 180 mmHg systolic).
- Inability to discontinue all prior anti-hypertensive 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 1 (week -2 to -4).
- Transient ischemic cerebral attack during the last 12 months prior to Visit 1 (week -2 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, valsartan, amlodipine | Drug | – |
Primary outcome
Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (Wk 4 and Wk 8)
3 secondary outcomes
Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (Wk 4 and Wk 8)
Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(Wk 4 and 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 12 Oct 2023.
- NOVARTIS PATIENT RECRUITMENT WEBSITELink provided by the sponsor.
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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
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+amlodipine combination, valsartan, amlodipine in people with Hypertension, run by Novartis at 1 site in Germany.
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 7 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 12 Oct 2023. 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 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 (Wk 4 and Wk 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 12 Oct 2023.