HypertensionPhase 3NCT02177422
Efficacy and Safety of Chronic Administration of Telmisartan as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension
A Phase 3 study testing Telmisartan and Hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
The primary objective of this trial was to assess the efficacy and safety of telmisartan 80 mg during open-label, long-term treatment. An additional objective was to assess the efficacy and safety of concomitant administration of telmisartan 80 mg and HCTZ (Hydrochlorothiazide) and/or any other therapies commonly used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- No sites listed yet
- Study dates
- Jun 1998to Nov 1999
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. All patients must give a separate written informed consent for participation in the open-label follow-up.
- Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer
- Mean seated systolic blood pressure ≥ 140 mmHg, measured my manual cuff
- A 24-hour mean diastolic blood pressure, measured by ABPM (ambulatory blood pressure measurement), of ≥ 85 mmHg
- Age 18 or older
- Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
Who cannot join
- Patients with a clinically significant change in ECG from baseline that was reported as an adverse event during the preceding clinical trial
- Patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan
- Patients who discontinued the preceding telmisartan clinical trial due to an adverse event
- Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
About this study
Official title: Open-Label Follow-up Trial on Efficacy and Safety of Chronic Administration of Telmisartan 80 mg (Micardis®) Tablets as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension
The primary objective of this trial was to assess the efficacy and safety of telmisartan 80 mg during open-label, long-term treatment. An additional objective was to assess the efficacy and safety of concomitant administration of telmisartan 80 mg and HCTZ (Hydrochlorothiazide) and/or any other therapies commonly used in the treatment of hypertension.
- Conditions
- Hypertension
- Being tested
- Telmisartan, Hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
telmisartan 80 mg once daily
HydrochlorothiazideDrug
12.5 mg or 25 mg Hydrochlorothiazide in addition to telmisartan in case that the goal response (mean sitting diastolic blood pressure < 90 mmHg) is not met after at least 4 weeks of treatment with telmisartan
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Not described Receives: Drug: Telmisartan; Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg
Measured: Up to one year
Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy
Measured: Up to one year
Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy
Measured: Up to one year
Mean sitting diastolic blood pressure during each visit
Measured: At months 3, 6, 9, 12
Mean sitting systolic blood pressure during each visit
Measured: At months 3, 6, 9, 12
Number of patient with adverse events
Measured: Up to one year
Changes from baseline in heart rate
Measured: Baseline and at months 3, 6, 9, 12
Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram)
Measured: Baseline and 12 months
Number of patients with abnormal changes in laboratory parameters
Measured: Baseline and 12 months
Number of patients with abnormal findings in physical examination
Measured: Baseline and at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 1998
- Primary completionNov 1999
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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 489 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
- NCT02177422
- Sponsor's protocol ID
- 502.260
- Status last verified
- Jul 2014
- First submitted
- 26 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Follow-up Trial on Efficacy and Safety of Chronic Administration of Telmisartan 80 mg (Micardis®) Tablets as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT02177422
- Acronym / sponsor ID
- 502.260
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Primary completion
- Nov 1999 (actual)
- First posted
- 27 Jun 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.
The primary objective of this trial was to assess the efficacy and safety of telmisartan 80 mg during open-label, long-term treatment. An additional objective was to assess the efficacy and safety of concomitant administration of telmisartan 80 mg and HCTZ (Hydrochlorothiazide) and/or any other therapies commonly used in the treatment of hypertension.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: Telmisartan, Drug: Hydrochlorothiazide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. All patients must give a separate written informed consent for participation in the open-label follow-up.
Key exclusion criteria (4 listed)
- Patients with a clinically significant change in ECG from baseline that was reported as an adverse event during the preceding clinical trial
- Patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan
- Patients who discontinued the preceding telmisartan clinical trial due to an adverse event
- Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
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 |
|---|---|---|
| Telmisartantelmisartan 80 mg once daily | Drug | Telmisartan |
| Hydrochlorothiazide12.5 mg or 25 mg Hydrochlorothiazide in addition to telmisartan in case that the goal response (mean sitting diastolic blood pressure < 90 mmHg) is not met after at least 4 weeks of treatment with telmisartan | Drug | Telmisartan |
Primary outcome
Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg
Time frame: Up to one year
Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy
Time frame: Up to one year
Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy
Time frame: Up to one year
Mean sitting diastolic blood pressure during each visit
Time frame: At months 3, 6, 9, 12
Mean sitting systolic blood pressure during each visit
Time frame: At months 3, 6, 9, 12
Number of patient with adverse events
Time frame: Up to one year
Changes from baseline in heart rate
Time frame: Baseline and at months 3, 6, 9, 12
Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram)
Time frame: Baseline and 12 months
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline and 12 months
Number of patients with abnormal findings in physical examination
Time frame: Baseline and at 12 month
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 8 Jul 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 Telmisartan and Hydrochlorothiazide 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 6 inclusion and 4 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 8 Jul 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?
Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg (time frame: Up to one year). The study lists 10 primary outcomes in all. 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 8 Jul 2014.