Essential HypertensionPhase 3NCT00430950
Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
A Phase 3 study testing olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets and olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg in people with Essential Hypertension, run by Daiichi Sankyo at 41 sites in 4 countries.
Trial summary
The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure. 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 (OM)+ hydrochlorothiazide (HCTZ) tablets and olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,011 participants
- Where
- 41 sitesin 4 countries
- Study dates
- Feb 2007to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)
Who cannot join
- Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
- Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
- Patients having a history of the following within the last six months:
- myocardial infarction,
- unstable angina pectoris,
- percutaneous coronary intervention,
Show all 11Show fewer
- severe heart failure,
- hypertensive encephalopathy, cerebrovascular accident (stroke) or
- transient ischaemic attack.
- Patients with clinically significant abnormal laboratory values at screening.
- Patients with secondary HTN.
Trial locations and contacts
41 sites in 4 countries.
41 sites in 4 countries
Netherlands15 sites
Study site
's-Hertogenbosch
Study site
Alphen aan den Rijn
Study site
Amsterdam-Zuidoost
Study site
Andijk
Study site
De Bilt
Study site
Ewijk
Study site
Heerlen
Study site
Hengelo
Study site
Landgraaf
Study site
Nijmegen
Study site
Oud-Beijerland
Study site
Ridderkerk
Study site
The Hague
Study site
Wildervank
Study site
Zwijndrecht
Germany14 sites
Study site
Berlin
Study site
Dortmund
Study site
Essen
Study site
Frankfurt
Study site
Goch
Study site
Hamburg
Study site
Kallstadt
Study site
Karlsruhe
Study site
Kassel
Study site
Magdeburg
Study site
Marburg
Study site
München
Study site
Wiesbaden
Study site
Wuppertal
Belgium6 sites
Study site
Bruges
Study site
Brussels
Study site
Drongen
Study site
Godinne
Study site
Mouscron
Study site
Wetteren
Slovakia6 sites
Study site
Bratislava
Study site
Levice
Study site
Lučenec
Study site
Nitra
Study site
Nové Zámky
Study site
Vráble
About this study
Official title: Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy
The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.
- Conditions
- Essential Hypertension
- Being tested
- olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets, olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
- Keywords
- Moderate-to-Severe Hypertension, Essential Hypertension, Combination Therapy, Fixed-Combination Dose
- 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 medoxomil (OM)+ hydrochlorothiazide (HCTZ) tabletsDrug
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mgDrug
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo Receives: Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets |
| 2 | Experimental | olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo Receives: Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Trough Sitting Diastolic Blood Pressure
Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.
Change = Week 16 - Week 8 (baseline).
Measured: 8 weeks
Secondary outcomes (4)
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
Change = Week 12 - Week 8 (baseline).
Measured: 4 weeks
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).
Measured: 8 weeks
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Change = Week 16 - Week 8 (baseline).
Measured: 8 weeks
Number of Participants Achieving Blood Pressure Goal.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Responsible party
- Sponsor
- Investigators
- Professor Lars Christian Rump, M.D., Study chair, University of Ruhr-Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430950
- Sponsor's protocol ID
- CS866CM-B-E302
- Status last verified
- Oct 2017
- First submitted
- 1 Feb 2007
- Last updated
- 10 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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/
Publications
Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.
PubMed 22114906
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy
- ClinicalTrials.gov ID
- NCT00430950
- Acronym / sponsor ID
- CS866CM-B-E302
- Conditions
- Essential Hypertension
- Keywords
- Moderate-to-Severe Hypertension, Essential Hypertension, Combination Therapy, Fixed-Combination Dose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Study start
- Feb 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 2 Feb 2007 (estimated)
- Results
- Posted 20 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tabletsolmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo |
| 2 | Experimental | Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mgolmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurements)
Key exclusion criteria (11 listed)
- Female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period.
- Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.
- Patients having a history of the following within the last six months:
- Patients with clinically significant abnormal laboratory values at screening.
- Patients with secondary HTN.
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 (OM)+ hydrochlorothiazide (HCTZ) tabletsolmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks | Drug | 1 |
| olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mgolmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks | Drug | 2 |
Primary outcome
Change in Mean Trough Sitting Diastolic Blood Pressure
Time frame: 8 weeks
Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline. Change = Week 16 - Week 8 (baseline).
4 secondary outcomes
Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12
Time frame: 4 weeks
Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
Time frame: 8 weeks
Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Time frame: 8 weeks
Number of Participants Achieving Blood Pressure Goal.
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22114906Rosenbaum D, Girerd X. Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension. Curr Med Res Opin. 2012 Feb;28(2):179-86. doi: 10.1185/03007995.2011.644626. Epub 2012 Jan 9.
- 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.
Professor Lars Christian Rump, M.D. study chair
University of Ruhr-Bochum
41 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets and olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg in people with Essential Hypertension, run by Daiichi Sankyo at 41 sites in 4 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 1 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 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Netherlands, Germany, Belgium, Slovakia. 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?
Yes. Results are posted in the registry (first posted 20 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Mean Trough Sitting Diastolic Blood Pressure (time frame: 8 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 NCT00430950, 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 10 Jan 2019.