Essential HypertensionPhase 3NCT00751751
Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly
A Phase 3 study testing olmesartan medoxomil + hydrochlorothiazide, if necessary and losartan + hydrochlorothiazide, if necessary in people with Essential Hypertension, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 1 site in Germany.
Trial summary
To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- olmesartan medoxomil + hydrochlorothiazide, if necessary and losartan + hydrochlorothiazide, if necessary
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2003to 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP >=150 mm HG
Who cannot join
- Secondary hypertension
- Malignant hypertension
- Severe heart failure (NYHA III-IV)
- History or evidence of renal disease
- Recent history of myocardial infarction
- Hypersensitivity to study drugs
- History of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.
To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.
- Conditions
- Essential Hypertension
- Being tested
- olmesartan medoxomil + hydrochlorothiazide, if necessary, losartan + hydrochlorothiazide, if necessary
- 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 + hydrochlorothiazide, if necessaryDrug
oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP
losartan + hydrochlorothiazide, if necessaryDrug
oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tablets, after 12 weeks, if needed to control BP.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | oral olmesartan medoxomil tablets 20 or 40 mg taken once daily for 52 weeks + hydrochlorothiazide tablets 12.5 or 25 mg , if needed to control BP after 12 weeks Receives: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary |
| 2 | Active comparator | oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tables, after 12 weeks, if needed to control BP. Receives: Drug: losartan + hydrochlorothiazide, if necessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean sitting diastolic blood pressure assessed by conventional BP measurements
Measured: 12 weeks
Secondary outcomes (2)
Change in mean sitting diastolic BP assessed by conventional BP measurements
Measured: after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks
Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP
Measured: after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJun 2003
- Primary completionApr 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
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter U Witte, MD, Ph.D., Principal investigator, IMFORM GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751751
- Sponsor's protocol ID
- SE-866/36
- Status last verified
- Sep 2008
- First submitted
- 11 Sep 2008
- Last updated
- 12 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.
- ClinicalTrials.gov ID
- NCT00751751
- Acronym / sponsor ID
- SE-866/36
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 12 Sep 2008 (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 assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.
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 + hydrochlorothiazide, if necessaryoral olmesartan medoxomil tablets 20 or 40 mg taken once daily for 52 weeks + hydrochlorothiazide tablets 12.5 or 25 mg , if needed to control BP after 12 weeks |
| 2 | Active comparator | Drug: losartan + hydrochlorothiazide, if necessaryoral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tables, after 12 weeks, if needed to control BP. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years or older
- Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP >=150 mm HG
Key exclusion criteria (7 listed)
- Secondary hypertension
- Malignant hypertension
- Severe heart failure (NYHA III-IV)
- History or evidence of renal disease
- Recent history of myocardial infarction
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 + hydrochlorothiazide, if necessaryoral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP | Drug | 1 |
| losartan + hydrochlorothiazide, if necessaryoral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tablets, after 12 weeks, if needed to control BP. | Drug | 2 |
Primary outcome
Change in mean sitting diastolic blood pressure assessed by conventional BP measurements
Time frame: 12 weeks
2 secondary outcomes
Change in mean sitting diastolic BP assessed by conventional BP measurements
Time frame: after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks
Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP
Time frame: after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 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 12 Sep 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.
Peter U Witte, MD, Ph.D. principal investigator
IMFORM GmbH
1 site 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, if necessary and losartan + hydrochlorothiazide, if necessary in people with Essential Hypertension, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 1 site 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 7 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 12 Sep 2008. 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 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?
Change in mean sitting diastolic blood pressure assessed by conventional BP measurements (time frame: 12 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 12 Sep 2008.