Essential HypertensionPhase 3NCT00220233
Olmesartan as an add-on to Amlodipine in Hypertension
A Phase 3 study testing olmesartan medoxomil, amlodipine and hydrochlorothiazide in people with Essential Hypertension, run by Sankyo Pharma Gmbh at 5 sites in Germany.
Trial summary
This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- olmesartan medoxomil, amlodipine and hydrochlorothiazide
- How many people
- 632 participants
- Where
- 5 sitesGermany
- Study dates
- Apr 2005to Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg
- Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg
Who cannot join
- Secondary hypertension
- Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Study site
Leipzig
Study site
Sinsheim
Study site
Tann
Study site
Weinheim
Study site
Wiesbaden
About this study
Official title: Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone
This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone
- Conditions
- Essential Hypertension
- Being tested
- olmesartan medoxomil, amlodipine, hydrochlorothiazide
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olmesartan medoxomilDrug
amlodipineDrug
hydrochlorothiazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in trough seated diastolic blood pressure
Secondary outcomes (4)
Mean change in trough seated systolic BP
Mean change in daytime, nighttime and 24 hour ambulatory blood pressure
Percent of patients achieving target blood pressure goal
Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- None (open label)
- Enrolment
- 632 participants
Sponsor and investigators
- Lead sponsor
- Sankyo Pharma Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Brommer, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220233
- Sponsor's protocol ID
- CS8663-A-E303
- Status last verified
- Dec 2007
- First submitted
- 16 Sep 2005
- Last updated
- 24 Dec 2018
- Results posted
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone
- ClinicalTrials.gov ID
- NCT00220233
- Acronym / sponsor ID
- CS8663-A-E303
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants
- Lead sponsor
- Sankyo Pharma GmbhIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 22 Sep 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.
This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg
- Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg
Key exclusion criteria (2 listed)
- Secondary hypertension
- Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
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 |
|---|---|---|
| olmesartan medoxomil | Drug | – |
| amlodipine | Drug | – |
| hydrochlorothiazide | Drug | – |
Primary outcome
Mean change in trough seated diastolic blood pressure
4 secondary outcomes
Mean change in trough seated systolic BP
Mean change in daytime, nighttime and 24 hour ambulatory blood pressure
Percent of patients achieving target blood pressure goal
Safety and tolerability
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 24 Dec 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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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.
Peter Brommer, MD principal investigator
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olmesartan medoxomil, amlodipine and hydrochlorothiazide in people with Essential Hypertension, run by Sankyo Pharma Gmbh at 5 sites 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 2 inclusion and 2 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 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Mean change in trough seated diastolic blood pressure. 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 24 Dec 2018.