HypertensionPhase 4NCT00265967
Irbesartan in Hypertension
A Phase 4 study testing Irbesartan in people with Hypertension, run by Sanofi at 1 site in Turkey (Türkiye).
Trial summary
Study objectives: To demonstrate the effect of irbesartan on the regulation of diastolic blood pressure, in case of missing one dose after a period of administration for 6 to 8 weeks To evaluate the safety of irbesartan Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Irbesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2005to Feb 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having an average value of ≥ 95 mmHg and ≤ 109 mmHg in diastolic blood pressure measurement or an average diastolic blood pressure value of ≥ 85 mmHg in 24-hours arterial blood pressure measurement,
- Received no treatment within the last 3 months.
Who cannot join
- Premenopausal women having at least one of the following conditions,
- Not surgically sterile,
- Are nursing,
- Having childbearing potential and not using a reasonable contraception method or not thinking to continue the method throughout the study. Reasonable contraception methods are: intrauterine device, oral or implantable or injectable contraception methods. No methods other than these are accepted.
- Patients routinely sleeping within the day since she/he works at nightshift and whose working hours continue in a time shift from midnight to 04:00 A.M.
- Patients with average systolic blood pressure = 180 mmHg in sitting position or average diastolic blood pressure is ≥110 mmHg in sitting position at baseline visit
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- Having known or suspected secondary hypertension
- Having renal and/or hepatic failure together with the following laboratory criteria:
- Having elevated values of SGPT (ALT) or SGOT (ALT) (at least twice the upper limit of normal range)
- Having serum creatinine levels of > 2.3 mg/dL (or > 203 μmol/L)
- With bilateral renal artery stenosis or single kidney and unilateral renal artery stenosis or those in post-renal transplantation or with single kidney,
- Having symptomatic sodium insufficiency, hypokalemia or hyperkalemia,
- With volume deficiency,
- With primary hyperaldosteronism,
- With biliary obstructive disorders,
- Having congestive heart failure (New York Heart Association (NYHA)-functional class CHF III-IV),
- With unstable angina pectoris occurring within 3 months before he or she signed the informed consent.
- With stroke occurring within 6 months before he or she signed the informed consent,
- With myocardial infarction or having cardiac surgery within three months before he or she signed the informed consent,
- Underwent PTCA (percutaneous transluminal coronary revascularization) within three months before he or she signed the informed consent,
- Having continuous tachycardia, atrial fibrillation, atrial flutter or other clinical arrythmias defined by the investigator
- With hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically related aortic or mitral valve stenosis,
- With insulin-dependant diabetes mellitus whose blood sugar regulation could not be controlled within the last 3 months after a HbA1C measurement in which it is equal to 10%.
- With a history of drug or alcohol addiction within the last 6 months before she or he signed the informed consent,
- Receiving a drug other than those defined in protocol for blood pressure regulation,
- Who have been participated in any investigational study within the prior month before she or he signed the informed consent
- With a known hypersensitivity against any drug which will be used.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Missed Dose Effect of Irbesartan in Hypertensive Patients and Cardiovascular Risk Profile Monitoring Under Irbesartan Treatment
Study objectives:
- To demonstrate the effect of irbesartan on the regulation of diastolic blood pressure, in case of missing one dose after a period of administration for 6 to 8 weeks
- To evaluate the safety of irbesartan
- Conditions
- Hypertension
- Being tested
- Irbesartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Irbesartan 150-300 mg/d for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Irbesartan Receives: Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 24 hours mean ambulatory blood pressure on the missing dose day. Frequency, severity, seriousness of adverse events emerging during the treatment , and their relation with the study drug.
Measured: at the end of 6th months to 8th
Secondary outcomes (1)
Diastolic blood pressure measurements recorded in patients' diaries, and during visits.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startSep 2005
- Primary completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Edibe Taylan, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265967
- Sponsor's protocol ID
- L_9917
- Status last verified
- Dec 2009
- First submitted
- 14 Dec 2005
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Missed Dose Effect of Irbesartan in Hypertensive Patients and Cardiovascular Risk Profile Monitoring Under Irbesartan Treatment
- ClinicalTrials.gov ID
- NCT00265967
- Acronym / sponsor ID
- L_9917
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2005
- Primary completion
- Feb 2007 (actual)
- First posted
- 15 Dec 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.
Study objectives:
- To demonstrate the effect of irbesartan on the regulation of diastolic blood pressure, in case of missing one dose after a period of administration for 6 to 8 weeks
- To evaluate the safety of irbesartan
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IrbesartanIrbesartan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having an average value of ≥ 95 mmHg and ≤ 109 mmHg in diastolic blood pressure measurement or an average diastolic blood pressure value of ≥ 85 mmHg in 24-hours arterial blood pressure measurement,
- Received no treatment within the last 3 months.
Key exclusion criteria (28 listed)
- Premenopausal women having at least one of the following conditions,
- Patients routinely sleeping within the day since she/he works at nightshift and whose working hours continue in a time shift from midnight to 04:00 A.M.
- Patients with average systolic blood pressure = 180 mmHg in sitting position or average diastolic blood pressure is ≥110 mmHg in sitting position at baseline visit
- Having known or suspected secondary hypertension
- Having renal and/or hepatic failure together with the following laboratory criteria:
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 |
|---|---|---|
| IrbesartanIrbesartan 150-300 mg/d for 8 weeks | Drug | 1 |
Primary outcome
Changes in 24 hours mean ambulatory blood pressure on the missing dose day. Frequency, severity, seriousness of adverse events emerging during the treatment , and their relation with the study drug.
Time frame: at the end of 6th months to 8th
1 secondary outcome
Diastolic blood pressure measurements recorded in patients' diaries, and during visits.
Time frame: 6-8 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 7 Dec 2009.
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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.
Edibe Taylan study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irbesartan in people with Hypertension, run by Sanofi at 1 site in Turkey (Türkiye).
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 28 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 7 Dec 2009. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes in 24 hours mean ambulatory blood pressure on the missing dose day. Frequency, severity, seriousness of adverse events emerging during the treatment , and their relation with the study drug. (time frame: at the end of 6th months to 8th). 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 7 Dec 2009.