Essential HypertensionPhase 3NCT00872586
Evaluation of the Additional Efficacy, and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension
A Phase 3 study testing olmesartan medoxomil + hydrochlorothiazide and olmesartan medoxomil in people with Essential Hypertension, run by Daiichi Sankyo at 8 sites in China.
Trial summary
This study is designed to evaluate the additional efficacy and safety of olmesartan medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil monotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- olmesartan medoxomil + hydrochlorothiazide and olmesartan medoxomil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 8 sitesChina
- Study dates
- Aug 2006to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At Visit 3, mean seated diastolic blood pressure (SeDBP) ≥ 95 mmHg and < 110 mmHg, AND mean seated systolic blood pressure (SeSBP) ≥140 mmHg and < 180 mmHg
- At Visit 4, mean SeDBP ≥ 90 mmH
- No significant disorder in blood, kidney, liver, cardiovascular system or endocrinology system
Who cannot join
- Patients with known or suspect secondary hypertension
- Unstable angina
- History of acute myocardial infarct, or PTCA or surgical cardiac procedures 3 months before entry into this study
- Prior or current congestive heart failure (NYHA grade III or IV), hypertrophic obstructive cardiomyopathy, valvular disease or rheumatic heart disease
- Arrhythmia of clinical significance
- Bilateral renal artery stenosis, isolated renal artery stenosis, post kidney transplantation
Show all 13Show fewer
- Acute glomerular nephritis
- Gout sufferers, even with the normal serum uric acid at entry
- Retinal hemorrhage /exudate
- Type 1 diabetes mellitus
- Uncontrolled type 2 diabetes mellitus
- Hypovolemia
- Patients with autoimmune disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Study site
Beijing
Study site
Chengdu
Study site
Chongqing
Study site
Guangzhou
Study site
Hangzhou
Study site
Nanjing
Study site
Shanghai
Study site
Wuhan
About this study
Official title: A Randomized, Double-blind, Double-dummy, Multicenter Clinical Trial to Evaluate the Additional Efficacy and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension, Who Fail to Attain the Blood Pressure Goals With Olmesartan Medoxomil 20mg Monotherapy
This study is designed to evaluate the additional efficacy and safety of olmesartan medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil monotherapy
- Conditions
- Essential Hypertension
- Being tested
- olmesartan medoxomil + hydrochlorothiazide, olmesartan medoxomil
- 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 + hydrochlorothiazideDrug
olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 20mg oral tablets + hydrochlorothiazide 12.5 mg oral tablets, once daily for up to 8 weeks
olmesartan medoxomilDrug
olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olmesartan medoxomil and hydrochlorothiazide Receives: Drug: olmesartan medoxomil + hydrochlorothiazide |
| 2 | Active comparator | olmesartan medoxomil Receives: Drug: olmesartan medoxomil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.
Measured: Baseline to12 weeks
Secondary outcomes (4)
The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups
Measured: 8 weeks (week 5 to week 12)
The mean change of trough seated diastolic blood pressure and seated systolic blood pressure from Week 5 to Week 9 between the two treatment groups
Measured: 5 weeks (Week 5 to week 9)
The response rate in the two treatment groups from baseline to Week 9
Measured: Baseline to 9 weeks
The response rate in the two treatment groups from baseline to Week 12
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startAug 2006
- Primary completionJul 2007
- 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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Sankyo Pharmaceuticals Co., Ltd.
- Investigators
- Naotaka Ikegami, VP, Study director, Shanghai Sankyo Pharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872586
- Sponsor's protocol ID
- SS-866 CMB/01
- Status last verified
- Sep 2010
- First submitted
- 27 Mar 2009
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Multicenter Clinical Trial to Evaluate the Additional Efficacy and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension, Who Fail to Attain the Blood Pressure Goals With Olmesartan Medoxomil 20mg Monotherapy
- ClinicalTrials.gov ID
- NCT00872586
- Acronym / sponsor ID
- SS-866 CMB/01
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Sankyo Pharmaceuticals Co., Ltd.
- Study start
- Aug 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 31 Mar 2009 (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 designed to evaluate the additional efficacy and safety of olmesartan medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: olmesartan medoxomil + hydrochlorothiazideOlmesartan medoxomil and hydrochlorothiazide |
| 2 | Active comparator | Drug: olmesartan medoxomilolmesartan medoxomil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At Visit 3, mean seated diastolic blood pressure (SeDBP) ≥ 95 mmHg and < 110 mmHg, AND mean seated systolic blood pressure (SeSBP) ≥140 mmHg and < 180 mmHg
- At Visit 4, mean SeDBP ≥ 90 mmH
- No significant disorder in blood, kidney, liver, cardiovascular system or endocrinology system
Key exclusion criteria (13 listed)
- Patients with known or suspect secondary hypertension
- Unstable angina
- History of acute myocardial infarct, or PTCA or surgical cardiac procedures 3 months before entry into this study
- Prior or current congestive heart failure (NYHA grade III or IV), hypertrophic obstructive cardiomyopathy, valvular disease or rheumatic heart disease
- Arrhythmia of clinical significance
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 + hydrochlorothiazideolmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 20mg oral tablets + hydrochlorothiazide 12.5 mg oral tablets, once daily for up to 8 weeks | Drug | 1 |
| olmesartan medoxomilolmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks | Drug | 2 |
Primary outcome
Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.
Time frame: Baseline to12 weeks
4 secondary outcomes
The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups
Time frame: 8 weeks (week 5 to week 12)
The mean change of trough seated diastolic blood pressure and seated systolic blood pressure from Week 5 to Week 9 between the two treatment groups
Time frame: 5 weeks (Week 5 to week 9)
The response rate in the two treatment groups from baseline to Week 9
Time frame: Baseline to 9 weeks
The response rate in the two treatment groups from baseline to Week 12
Time frame: Baseline to 12 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 29 Sep 2010.
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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.
Naotaka Ikegami, VP study director
Shanghai Sankyo Pharmaceuticals Co., Ltd.
8 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 + hydrochlorothiazide and olmesartan medoxomil in people with Essential Hypertension, run by Daiichi Sankyo at 8 sites in China.
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 13 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 29 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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 of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups. (time frame: Baseline to12 weeks). 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 29 Sep 2010.