Isolated Systolic HypertensionPhase 3NCT00751829
Isolated Systolic Hypertension in the Elderly and Very Elderly
A Phase 3 study testing olmesartan medoxomil + hydrochlorothiazide, if necessary and nitrendipine + hydrochlorothiazide, if necessary in people with Isolated Systolic Hypertension, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 1 site in Germany.
Trial summary
To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Isolated Systolic Hypertension
- What is being tested?
- olmesartan medoxomil + hydrochlorothiazide, if necessary and nitrendipine + hydrochlorothiazide, if necessary
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2003to Feb 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 or older
- Mean sitting BP >160 mmHg and mean sitting dBP<90 mmHg
Who cannot join
- Secondary hypertension
- Malignant hypertension
- Severe Heart Failure (NYHA III-IV)
- Recent history of myocardial infarction
- Hypersensitivity to study medications
- History of drug or alcohol abuse
- History or evidence of renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension
To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.
- Conditions
- Isolated Systolic Hypertension
- Being tested
- olmesartan medoxomil + hydrochlorothiazide, if necessary, nitrendipine + hydrochlorothiazide, if necessary
- Medical subject headings
- Isolated Systolic 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 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
nitrendipine + hydrochlorothiazide, if necessaryDrug
oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to controll BP Receives: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary |
| 2 | Active comparator | oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP Receives: Drug: nitrendipine + hydrochlorothiazide, if necessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean sitting systolic blood pressure as assessed by conventional BP measurements
Measured: 12 weeks
Secondary outcomes (2)
Change in mean sitting systolic blood pressure assessed by conventional BP measurements
Measured: After 1, 2, 4, 8, 12, 16, 20, and 24 weeks
Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP
Measured: after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment
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 startJul 2003
- Primary completionOct 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated Systolic 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
- 417 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
- NCT00751829
- Sponsor's protocol ID
- SE-866/37
- Status last verified
- May 2023
- First submitted
- 11 Sep 2008
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension
- ClinicalTrials.gov ID
- NCT00751829
- Acronym / sponsor ID
- SE-866/37
- Conditions
- Isolated Systolic Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Feb 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 evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.
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 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to controll BP |
| 2 | Active comparator | Drug: nitrendipine + hydrochlorothiazide, if necessaryoral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily 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 or older
- Mean sitting BP >160 mmHg and mean sitting dBP<90 mmHg
Key exclusion criteria (7 listed)
- Secondary hypertension
- Malignant hypertension
- Severe Heart Failure (NYHA III-IV)
- Recent history of myocardial infarction
- Hypersensitivity to study medications
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 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP | Drug | 1 |
| nitrendipine + hydrochlorothiazide, if necessaryoral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP | Drug | 2 |
Primary outcome
Change in mean sitting systolic blood pressure as assessed by conventional BP measurements
Time frame: 12 weeks
2 secondary outcomes
Change in mean sitting systolic blood pressure assessed by conventional BP measurements
Time frame: After 1, 2, 4, 8, 12, 16, 20, and 24 weeks
Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP
Time frame: after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment
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 1 Jun 2023.
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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 nitrendipine + hydrochlorothiazide, if necessary in people with Isolated Systolic 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 1 Jun 2023. 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 systolic blood pressure as 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 1 Jun 2023.