Essential HypertensionPhase 3NCT00185172
Olmesartan in Essential Hypertension
A Phase 3 study testing olmesartan medoxomil and olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets in people with Essential Hypertension, run by Sankyo Pharma Gmbh at 8 sites in 8 countries.
Trial summary
To test the efficacy and safety of olmesartan in patients with essential hypertension. 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 and olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,333 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Jan 2002to Jun 2005
- 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
- Age: 18 (19 if required by local authorities) to 75 years
- Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized
- Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg
- Written Informed Consent
- Mentally competent
- Negative pregnancy test in women at a childbearing age at the beginning of the study
Who cannot join
- Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension
- Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months
- Patients with a history or current evidence of congestive heart failure
- Bilateral renal artery stenosis
- Severe renal insufficiency (serum creatinine greater than 200 micro mol/l)
- Severe hepatic impairment or biliary obstruction
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Switzerland1 site
PFC Pharma Focus Consultants AG
Zurich, Volketswil, 8604
About this study
Official title: Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension
To test the efficacy and safety of olmesartan in patients with essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- placebo, olmesartan medoxomil, olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Placebo oral tablets for 2 weeks
olmesartan medoxomilDrug
olmesartan medoxomil oral tablets for 8 weeks
olmesartan medoxomil oral tablets, hydrochlorothiazide oral tabletsDrug
olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 2 week placebo run-in Receives: Other: placebo |
| 2 | Experimental | Olmesartan medoxomil tablets for 8 weeks Receives: Drug: olmesartan medoxomil |
| 3 | Experimental | Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks Receives: Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan.
Measured: From week 8 to week 12
Secondary outcomes (2)
To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12.
Measured: 12 weeks
To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionJun 2005
- Study completionJun 2005
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sankyo Pharma Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Prof. Michael Bohm, MD, Principal investigator, Universitatskliniken des Saarlandes, Homburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185172
- Sponsor's protocol ID
- SP-OLM-01-00
- Status last verified
- Apr 2008
- First submitted
- 12 Sep 2005
- Last updated
- 29 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT00185172
- Acronym / sponsor ID
- SP-OLM-01-00
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,333 participants (actual)
- Lead sponsor
- Sankyo Pharma GmbhIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 16 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.
To test the efficacy and safety of olmesartan in patients with essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: placebo2 week placebo run-in |
| 2 | Experimental | Drug: olmesartan medoxomilOlmesartan medoxomil tablets for 8 weeks |
| 3 | Experimental | Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tabletsOlmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 (19 if required by local authorities) to 75 years
- Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized
- Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg
- Written Informed Consent
- Mentally competent
Key exclusion criteria (6 listed)
- Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension
- Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months
- Patients with a history or current evidence of congestive heart failure
- Bilateral renal artery stenosis
- Severe renal insufficiency (serum creatinine greater than 200 micro mol/l)
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 |
|---|---|---|
| placeboPlacebo oral tablets for 2 weeks | Other | 1 |
| olmesartan medoxomilolmesartan medoxomil oral tablets for 8 weeks | Drug | 2 |
| olmesartan medoxomil oral tablets, hydrochlorothiazide oral tabletsolmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets | Drug | 3 |
Primary outcome
To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan.
Time frame: From week 8 to week 12
2 secondary outcomes
To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12.
Time frame: 12 weeks
To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.
Time frame: 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 Apr 2008.
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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.
Prof. Michael Bohm, MD principal investigator
Universitatskliniken des Saarlandes, Homburg, Germany
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olmesartan medoxomil and olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets in people with Essential Hypertension, run by Sankyo Pharma Gmbh at 8 sites in 8 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 6 inclusion and 6 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 Apr 2008. 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 Austria, Germany, Italy, Netherlands, Portugal and 3 more countries. 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. Some participants in this study may receive a placebo. 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?
To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan. (time frame: From week 8 to week 12). 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 Apr 2008.