HypertensionPhase 3NCT02269176
Efficacy and Safety of Telmisartan and Losartan in Primary Hypertension
A Phase 3 study testing Low dose of telmisartan, High dose of telmisartan and Low dose of losartan in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the treatment of the mild to moderate primary hypertension patients in China Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Low dose of telmisartan, High dose of telmisartan and Low dose of losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Jan 2001
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mild to moderate primary hypertension, the mean sitting valley value of diastolic blood pressure (DBP) ≥ 95 and < 110 mmHg, and the mean sitting valley value of systolic blood pressure (SBP) < 180 mmHg
Who cannot join
- Not specified
About this study
Official title: 12 Week, Multi-center, Randomized, Double-blind, Double Dummy, Parallel Group Trial Comparing the Efficacy and Safety of 40 & 80 mg Telmisartan and 50 & 100 mg Losartan in the Treatment of 150 Pairs of Primary Hypertension Patients
Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the treatment of the mild to moderate primary hypertension patients in China
- Conditions
- Hypertension
- Being tested
- Low dose of telmisartan, High dose of telmisartan, Low dose of losartan, High dose of losartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of telmisartanDrug
High dose of telmisartanDrug
Low dose of losartanDrug
High dose of losartanDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Low dose of telmisartan, uptitrated to high dose in case no sufficient effect is observered Receives: Drug: Low dose of telmisartan; Drug: High dose of telmisartan |
| Losartan | Active comparator | Low dose of losartan, uptitrated to high dose in case no sufficient effect is observered Receives: Drug: Low dose of losartan; Drug: High dose of losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean sitting valley value of DBP
The valley value of blood pressure refers to the blood pressure measured prior to the next administration of antihypertensives
Measured: 8 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJul 2000
- Primary completionJan 2001
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 Boehringer IngelheimThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269176
- Sponsor's protocol ID
- 502.365
- Status last verified
- Oct 2014
- First submitted
- 20 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Week, Multi-center, Randomized, Double-blind, Double Dummy, Parallel Group Trial Comparing the Efficacy and Safety of 40 & 80 mg Telmisartan and 50 & 100 mg Losartan in the Treatment of 150 Pairs of Primary Hypertension Patients
- ClinicalTrials.gov ID
- NCT02269176
- Acronym / sponsor ID
- 502.365
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- Primary completion
- Jan 2001 (actual)
- First posted
- 21 Oct 2014 (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.
Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the treatment of the mild to moderate primary hypertension patients in China
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: Low dose of telmisartan, Drug: High dose of telmisartanLow dose of telmisartan, uptitrated to high dose in case no sufficient effect is observered |
| Losartan | Active comparator | Drug: Low dose of losartan, Drug: High dose of losartanLow dose of losartan, uptitrated to high dose in case no sufficient effect is observered |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate primary hypertension, the mean sitting valley value of diastolic blood pressure (DBP) ≥ 95 and < 110 mmHg, and the mean sitting valley value of systolic blood pressure (SBP) < 180 mmHg
Key exclusion criteria (1 listed)
- Not specified
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 |
|---|---|---|
| Low dose of telmisartan | Drug | Telmisartan |
| High dose of telmisartan | Drug | Telmisartan |
| Low dose of losartan | Drug | Losartan |
| High dose of losartan | Drug | Losartan |
Primary outcome
Changes in mean sitting valley value of DBP
Time frame: 8 weeks after start of treatment
The valley value of blood pressure refers to the blood pressure measured prior to the next administration of antihypertensives
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 21 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low dose of telmisartan, High dose of telmisartan and Low dose of losartan in people with Hypertension, run by Boehringer Ingelheim.
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 1 inclusion and 1 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 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in mean sitting valley value of DBP (time frame: 8 weeks after start of treatment). 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 21 Oct 2014.