HypertensionPhase 4NCT00241124
Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes
A Phase 4 study testing valsartan and lisinopril in people with Hypertension, run by Novartis at 1 site in Germany.
Trial summary
A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the morning and comparing a morning dose of Valsartan with an evening dose. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan and lisinopril
- How many people
- 1,099 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to Jun 2005
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Hypertension defined by a MSSBP >=150 mmHg (untreated patients) or patients on current anti-hypertensive treatment who remain uncontrolled (i.e. MSSBP >140 mmHg)
- Randomisation mean 24h blood pressure above 130/80 mmHg
- In addition the patients must fulfill, at least, one of the following criteria:
- Controlled type II Diabetes mellitus Hypercholesteremia, currently treated with lipid-lowering drugs Metabolic syndrome MI, CABG or PTCA more than one year ago Stroke or transient ischemic cerebral attack more than one year ago Documented history of peripheral vascular disease, increased IMT, or carotid plaques Documented history of LVH Elderly >65 years
Who cannot join
- - MSSBP >=180 mmHg and/or MSDBP >= 110 mmHg at any time from Visit 1 to Visit 3
- Inability to discontinue all prior anti-hypertensive medications safely for a period of three weeks
- Mandatory indication for any concomitant medication for coronary artery disease or any other disease that is not allowed during this study.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Double Dummy, Parallel Group, Active-Controlled Study To Evaluate The Effectiveness Of Morning Versus Evening Doses Of 320 Mg Valsartan Versus 40 Mg Lisinopril On The 24 Hour Blood Pressure Profile In Patients With Hypertension And Non-Insulin Dependent Diabetes
A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the morning and comparing a morning dose of Valsartan with an evening dose.
- Conditions
- Hypertension
- Being tested
- valsartan, lisinopril
- Keywords
- hypertension, valsartan, morning/evening dosing, lisinopril
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
lisinoprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks
Change from baseline in systolic 24 hour blood pressure after 12 weeks
Secondary outcomes (5)
Change from baseline manual blood pressure and pulse pressure after 26 weeks
Change from baseline markers of endothelial function, fibrosis, and other blood measurements of hypertension after 12 and 26 weeks
Changes in ambulatory blood pressure measurements at various timepoints up to 26 weeks
Change from baseline heart size after 26 weeks
Adverse events, serious adverse events, laboratory values, physical examinations, vital signs for up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startApr 2004
- Primary completionJun 2005
- Study completionJun 2005
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
- 1,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241124
- Sponsor's protocol ID
- CVAL489A2420
- Status last verified
- Nov 2011
- First submitted
- 14 Oct 2005
- Last updated
- 23 Nov 2011
- Results posted
- No
Publications
Zappe DH, Crikelair N, Kandra A, Palatini P. Time of administration important? Morning versus evening dosing of valsartan. J Hypertens. 2015 Feb;33(2):385-92. doi: 10.1097/HJH.0000000000000397.
PubMed 25259546
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Double Dummy, Parallel Group, Active-Controlled Study To Evaluate The Effectiveness Of Morning Versus Evening Doses Of 320 Mg Valsartan Versus 40 Mg Lisinopril On The 24 Hour Blood Pressure Profile In Patients With Hypertension And Non-Insulin Dependent Diabetes
- ClinicalTrials.gov ID
- NCT00241124
- Acronym / sponsor ID
- CVAL489A2420
- Conditions
- Hypertension
- Keywords
- hypertension, valsartan, morning/evening dosing, lisinopril
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,099 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 18 Oct 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.
A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the morning and comparing a morning dose of Valsartan with an evening dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Hypertension defined by a MSSBP >=150 mmHg (untreated patients) or patients on current anti-hypertensive treatment who remain uncontrolled (i.e. MSSBP >140 mmHg)
- Randomisation mean 24h blood pressure above 130/80 mmHg
- In addition the patients must fulfill, at least, one of the following criteria:
- Controlled type II Diabetes mellitus Hypercholesteremia, currently treated with lipid-lowering drugs Metabolic syndrome MI, CABG or PTCA more than one year ago Stroke or transient ischemic cerebral attack more than one year ago Documented history of peripheral vascular disease, increased IMT, or carotid plaques Documented history of LVH Elderly >65 years
Key exclusion criteria (4 listed)
- - MSSBP >=180 mmHg and/or MSDBP >= 110 mmHg at any time from Visit 1 to Visit 3
- Inability to discontinue all prior anti-hypertensive medications safely for a period of three weeks
- Mandatory indication for any concomitant medication for coronary artery disease or any other disease that is not allowed during this study.
- Other protocol-defined exclusion criteria may 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 | – |
| lisinopril | Drug | – |
Primary outcome
Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks
Change from baseline in systolic 24 hour blood pressure after 12 weeks
5 secondary outcomes
Change from baseline manual blood pressure and pulse pressure after 26 weeks
Change from baseline markers of endothelial function, fibrosis, and other blood measurements of hypertension after 12 and 26 weeks
Changes in ambulatory blood pressure measurements at various timepoints up to 26 weeks
Change from baseline heart size after 26 weeks
Adverse events, serious adverse events, laboratory values, physical examinations, vital signs for up to 26 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 Nov 2011.
- Derived from this study: PubMed 25259546Zappe DH, Crikelair N, Kandra A, Palatini P. Time of administration important? Morning versus evening dosing of valsartan. J Hypertens. 2015 Feb;33(2):385-92. doi: 10.1097/HJH.0000000000000397.
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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 valsartan and lisinopril 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 4 inclusion and 4 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 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 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 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?
Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks. The study lists 2 primary outcomes in all. 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 NCT00241124, 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 Nov 2011.