HypertensionPhase 4NCT00139555
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
A Phase 4 study testing amlodipine/benazepril in people with Hypertension and Left Ventricular Hypertrophy, run by Novartis at 1 site in United States.
Trial summary
Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and mortality in patients with high blood pressure, compared to those without LVH. Reduction of left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical outcome. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hypertension, Left Ventricular Hypertrophy
- What is being tested?
- amlodipine/benazepril
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Nov 2006
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or female patients ≥ 55 years of age
- LVH as confirmed by echocardiogram
- Patients with high risk hypertension, currently treated or already taking antihypertensive medication
Who cannot join
- Renal artery stenosis
- Symptomatic heart failure or known ejection fraction < 40%
- Myocardial infarction or stroke within 6 months
- Presence of cranial aneurysm clips, coronary artery metal stents and pacemakers
- Pregnant or lactating females
- Cancer within the last 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and mortality in patients with high blood pressure, compared to those without LVH. Reduction of left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in patients with high risk hypertension.
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Being tested
- amlodipine/benazepril
- Keywords
- Hypertension, Left ventricular hypertrophy
- Medical subject headings
- Hypertension, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine/benazeprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in left ventricular mass index after 52 weeks
Secondary outcomes (4)
Change from baseline in left ventricular mass after 52 weeks
Change from baseline in diastolic function after 52 weeks
Change from baseline in aorta function assessed blood pressure measurements after 52 weeks
Change from baseline in markers of fibrosis and increased heart size after 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionNov 2006
- Study completionNov 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139555
- Sponsor's protocol ID
- CCIB002FUS16
- Status last verified
- Feb 2017
- First submitted
- 29 Aug 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Reichek N, Devereux RB, Rocha RA, Hilkert R, Hall D, Purkayastha D, Pitt B. Magnetic resonance imaging left ventricular mass reduction with fixed-dose angiotensin-converting enzyme inhibitor-based regimens in patients with high-risk hypertension. Hypertension. 2009 Oct;54(4):731-7. doi: 10.1161/HYPERTENSIONAHA.109.130641. Epub 2009 Aug 17.
PubMed 19687350
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
- ClinicalTrials.gov ID
- NCT00139555
- Acronym / sponsor ID
- CCIB002FUS16
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Keywords
- Hypertension, Left ventricular hypertrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 31 Aug 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.
Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and mortality in patients with high blood pressure, compared to those without LVH. Reduction of left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in patients with high risk hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or female patients ≥ 55 years of age
- LVH as confirmed by echocardiogram
- Patients with high risk hypertension, currently treated or already taking antihypertensive medication
Key exclusion criteria (6 listed)
- Renal artery stenosis
- Symptomatic heart failure or known ejection fraction < 40%
- Myocardial infarction or stroke within 6 months
- Presence of cranial aneurysm clips, coronary artery metal stents and pacemakers
- Pregnant or lactating females
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 |
|---|---|---|
| amlodipine/benazepril | Drug | – |
Primary outcome
Change from baseline in left ventricular mass index after 52 weeks
4 secondary outcomes
Change from baseline in left ventricular mass after 52 weeks
Change from baseline in diastolic function after 52 weeks
Change from baseline in aorta function assessed blood pressure measurements after 52 weeks
Change from baseline in markers of fibrosis and increased heart size after 52 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 23 Feb 2017.
- Results publication: PubMed 19687350Reichek N, Devereux RB, Rocha RA, Hilkert R, Hall D, Purkayastha D, Pitt B. Magnetic resonance imaging left ventricular mass reduction with fixed-dose angiotensin-converting enzyme inhibitor-based regimens in patients with high-risk hypertension. Hypertension. 2009 Oct;54(4):731-7. doi: 10.1161/HYPERTENSIONAHA.109.130641. Epub 2009 Aug 17.
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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
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 4 study testing amlodipine/benazepril in people with Hypertension and Left Ventricular Hypertrophy, run by Novartis at 1 site in United States.
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 6 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 23 Feb 2017. 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 United States. 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?
Change from baseline in left ventricular mass index after 52 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 NCT00139555, 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 23 Feb 2017.