Essential HypertensionPhase 3NCT00151827
Olmesartan Medoxomil in Hypertension and Renal Impairment
A Phase 3 study testing Olmesartan medoxomil, Losartan and Furosemide oral tablets in people with Essential Hypertension and Renal Impairment, run by Sankyo Pharma Gmbh at 1 site in Germany.
Trial summary
This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension, Renal Impairment
- What is being tested?
- Olmesartan medoxomil, Losartan and Furosemide oral tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2003to Jul 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
- Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
- Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity
Who cannot join
- Malignant hypertension or sitting BP greater than 180/109 mmHg;
- Severe heart failure, severe renal disease;
- Recent history of myocardial infarction, stroke or transient ischemic attack;
- History, clinical or current 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;
- Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
- Treatment with dis-allowed medication;
- Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
- History of drug and/or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment
This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.
- Conditions
- Essential Hypertension, Renal Impairment
- Being tested
- Olmesartan medoxomil, Losartan, Furosemide oral tablets
- Medical subject headings
- Essential Hypertension, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomilDrug
Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
LosartanDrug
Medications are taken once daily before breakfast with water.
Furosemide oral tabletsDrug
If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator
| Study group | Role | What they receive |
|---|---|---|
| Olmesartan medoxomil | Experimental | Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water. Receives: Drug: Olmesartan medoxomil; Drug: Furosemide oral tablets |
| Losartan | Experimental | Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo. Receives: Drug: Losartan; Drug: Furosemide oral tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment
Measured: Baseline to 12 weeks
Secondary outcomes (7)
Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
Measured: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
Measured: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;
Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg
Measured: Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks
Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;
Measured: Baseline to 12 and 52 weeks
Changes in serum creatinine after 12 and 52 weeks of treatment
Measured: Baseline to 12 and 52 weeks
Rate of patients per dose level after 12 and 52 weeks of treatment
Measured: Baseline to 12 and 52 weeks
Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment
Measured: Baseline to 4, 12, 24, 36 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 posted9 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionJul 2005
- Study completionJul 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
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sankyo Pharma Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- P. U. Witte, MD, PhD, Principal investigator, IMFORM GmbH, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151827
- Sponsor's protocol ID
- SE-866/43
- Status last verified
- Oct 2010
- First submitted
- 8 Sep 2005
- Last updated
- 14 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment
- ClinicalTrials.gov ID
- NCT00151827
- Acronym / sponsor ID
- SE-866/43
- Conditions
- Essential Hypertension, Renal Impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Sankyo Pharma GmbhIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 9 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 mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olmesartan medoxomil | Experimental | Drug: Olmesartan medoxomil, Drug: Furosemide oral tabletsOlmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water. |
| Losartan | Experimental | Drug: Losartan, Drug: Furosemide oral tabletsLosartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mean sitting BP prior to randomization of 140-180/90-109 mmHg;
- Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity
Key exclusion criteria (8 listed)
- Malignant hypertension or sitting BP greater than 180/109 mmHg;
- Severe heart failure, severe renal disease;
- Recent history of myocardial infarction, stroke or transient ischemic attack;
- History, clinical or current 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;
- Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
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 medoxomilOlmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water. | Drug | Olmesartan medoxomil |
| LosartanMedications are taken once daily before breakfast with water. | Drug | Losartan |
| Furosemide oral tabletsIf its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator | Drug | Losartan, Olmesartan medoxomil |
Primary outcome
Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment
Time frame: Baseline to 12 weeks
7 secondary outcomes
Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
Time frame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment;
Time frame: Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks
Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment;
Time frame: Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks
Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment;
Time frame: Baseline to 12 and 52 weeks
Changes in serum creatinine after 12 and 52 weeks of treatment
Time frame: Baseline to 12 and 52 weeks
Rate of patients per dose level after 12 and 52 weeks of treatment
Time frame: Baseline to 12 and 52 weeks
Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment
Time frame: Baseline to 4, 12, 24, 36 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 14 Oct 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.
P. U. Witte, MD, PhD principal investigator
IMFORM GmbH, Darmstadt, 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, Losartan and Furosemide oral tablets in people with Essential Hypertension and Renal Impairment, 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 2 inclusion and 8 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 Oct 2010. 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 (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment (time frame: Baseline to 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 14 Oct 2010.