Essential HypertensionPhase 3NCT00185185
Olmesartan Medoxomil in Atherosclerosis
A Phase 3 study testing Olmesartan medoxomil, Atenolol and Hydrochlorothiazide in people with Essential Hypertension and Atherosclerotic Cardiovascular Disease, run by Sankyo Pharma Gmbh at 1 site in Germany.
Trial summary
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Essential Hypertension, Atherosclerotic Cardiovascular Disease
- What is being tested?
- Olmesartan medoxomil, Atenolol and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2001to Feb 2006
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mean sitting sBP and dBP prior to randomization of 140-180/90-105 mmHg
- Increased cardiovascular risk, e.g.: a) documented or clinical signs of peripheral atherosclerotic disease stage IIa or lower; b) diabetes mellitus type 2; c) left ventricular hypertrophy on echo; d) current smoking; e) old myocardial infarction, stroke or TIA
- Intima-media thickness of the common carotid artery greater than or equal to 0.8 and less than or equal to 1.6 mm (measured ultrasonographically) or the plaque volume of the carotid bulb greater than or equal to 4 μl and less than or equal to 500 μl
Who cannot join
- Body mass index > 30
- Any type of known secondary hypertension
- Electrocardiographic evidence of 2nd or 3rd degree atrioventricular block, atrial fibrillation, cardiac arrhythmia requiring therapy or bradycardia at rest (< 50/min)
- Obstructive pulmonary disease
- Claudicatio intermittens
- History or clinical evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial
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- Hypersensitivity or contraindication to ARBs, Beta-Blockers, HCTZ or any cross allergy
- Pre-treatment with ARBs or ACE inhibitors within 6 months prior to screening
- Treatment with disallowed medication
- Pregnant or breastfeeding females or females of childbearing potential without adequate contraception
- History of alcohol and/or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
- Being tested
- Olmesartan medoxomil, Atenolol, Hydrochlorothiazide
- Medical subject headings
- Essential Hypertension, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomilDrug
AtenololDrug
HydrochlorothiazideDrug
tablets
olmesartan medoxomilDrug
tablets
atenololDrug
tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | olmesartan medoxomil Receives: Drug: Olmesartan medoxomil; Drug: Hydrochlorothiazide |
| 2 | Active comparator | atenolol Receives: Drug: Atenolol; Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of intima media thickness of the common carotid artery on the leading side of the neck.
Secondary outcomes (4)
-Change in plaque volume in the common carotid artery or the carotid bulb.
-Change of intima media thickness of the common carotid artery.
-Changes of diastolic and systolic blood pressure.
-Safety and tolerability
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 startNov 2001
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sankyo Pharma Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Prof. Klaus O Stumpe, MD, Principal investigator, Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185185
- Sponsor's protocol ID
- SE-866/27
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 14 Dec 2007
- Results posted
- No
Publications
Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
PubMed 37565307
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
- ClinicalTrials.gov ID
- NCT00185185
- Acronym / sponsor ID
- SE-866/27
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Sankyo Pharma GmbhIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Study completion
- Feb 2006 (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.
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
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, Drug: Hydrochlorothiazideolmesartan medoxomil |
| 2 | Active comparator | Drug: Atenolol, Drug: Hydrochlorothiazideatenolol |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mean sitting sBP and dBP prior to randomization of 140-180/90-105 mmHg
- Increased cardiovascular risk, e.g.: a) documented or clinical signs of peripheral atherosclerotic disease stage IIa or lower; b) diabetes mellitus type 2; c) left ventricular hypertrophy on echo; d) current smoking; e) old myocardial infarction, stroke or TIA
- Intima-media thickness of the common carotid artery greater than or equal to 0.8 and less than or equal to 1.6 mm (measured ultrasonographically) or the plaque volume of the carotid bulb greater than or equal to 4 μl and less than or equal to 500 μl
Key exclusion criteria (11 listed)
- Body mass index > 30
- Any type of known secondary hypertension
- Electrocardiographic evidence of 2nd or 3rd degree atrioventricular block, atrial fibrillation, cardiac arrhythmia requiring therapy or bradycardia at rest (< 50/min)
- Obstructive pulmonary disease
- Claudicatio intermittens
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 | Drug | 1 |
| Atenolol | Drug | 2 |
| Hydrochlorothiazidetablets | Drug | 1, 2 |
| olmesartan medoxomiltablets | Drug | 1 |
| atenololtablets | Drug | 2 |
Primary outcome
Change of intima media thickness of the common carotid artery on the leading side of the neck.
4 secondary outcomes
-Change in plaque volume in the common carotid artery or the carotid bulb.
-Change of intima media thickness of the common carotid artery.
-Changes of diastolic and systolic blood pressure.
-Safety and tolerability
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 14 Dec 2007.
- Derived from this study: PubMed 37565307Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
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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. Klaus O Stumpe, MD principal investigator
Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany
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, Atenolol and Hydrochlorothiazide in people with Essential Hypertension and Atherosclerotic Cardiovascular Disease, run by Sankyo Pharma Gmbh 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 3 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 14 Dec 2007. 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 of intima media thickness of the common carotid artery on the leading side of the neck.. 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 NCT00185185, 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 14 Dec 2007.