HypertensionPhase 4NCT00858702
Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
A Phase 4 study testing olmesartan medoxomil and a CCB and olmesartan medoxomil and a diuretic in people with Hypertension, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil… Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Hypertension
- What is being tested?
- olmesartan medoxomil and a CCB and olmesartan medoxomil and a diuretic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2005to Nov 2005
- Phase
- Phase 4
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
- Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil
Who cannot join
- Patients with secondary hypertension
- Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone
The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone
- Conditions
- Hypertension
- Being tested
- olmesartan medoxomil and a CCB, olmesartan medoxomil and a diuretic
- Keywords
- Essential hypertension, Combination therapy
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olmesartan medoxomil and a CCBDrug
olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks
olmesartan medoxomil and a diureticDrug
olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | olmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks Receives: Drug: olmesartan medoxomil and a CCB |
| 2 | Experimental | olmesartan medoxomil and a diuretic tablet (of the thiazide class) Receives: Drug: olmesartan medoxomil and a diuretic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
Measured: Baseline to week 8
Secondary outcomes (2)
Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.
Measured: At week 8
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.
Measured: At week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startFeb 2005
- Primary completionJul 2005
- Study completionNov 2005
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.
- 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
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Research and Development Division, Study director, Daiichi Sankyo Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858702
- Sponsor's protocol ID
- OLM004-071
- Status last verified
- Oct 2017
- First submitted
- 9 Mar 2009
- Last updated
- 11 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone
- ClinicalTrials.gov ID
- NCT00858702
- Acronym / sponsor ID
- OLM004-071
- Conditions
- Hypertension
- Keywords
- Essential hypertension, Combination therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Posted 26 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olmesartan medoxomil and a CCBolmesartan medoxomil tablets and a CCB tablet (of the dihydropyridine class), once daily for 8 weeks |
| 2 | Experimental | Drug: olmesartan medoxomil and a diureticolmesartan medoxomil and a diuretic tablet (of the thiazide class) |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
- Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil
Key exclusion criteria (2 listed)
- Patients with 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 and a CCBolmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks | Drug | 1 |
| olmesartan medoxomil and a diureticolmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks | Drug | 2 |
Primary outcome
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
Time frame: Baseline to week 8
2 secondary outcomes
Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
Time frame: At week 8
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
Time frame: At week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Research and Development Division study director
Daiichi Sankyo Co., Ltd.
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 olmesartan medoxomil and a CCB and olmesartan medoxomil and a diuretic in people with Hypertension, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
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 11 Oct 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 Japan. 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?
Yes. Results are posted in the registry (first posted 26 Aug 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?
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 (time frame: Baseline to week 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 11 Oct 2017.