HypertensionPhase 3NCT02177487
Safety Evaluation of Telmisartan Plus Hydrochlorothiazide in Patients With Mild-to-Moderate Hypertension
A Phase 3 study testing Telmisartan/hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to assess the safety of six month of open-label, treatment with the fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients with mild-to-moderate hypertension who completed the eight week randomized, double blind 502.261 study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan/hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 1999to Jan 2000
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who were randomized and completed all study visits of the preceding double-blind trial with the fixed dose combination (502.261) who meet the following criteria:
- Patients that are not controlled on telmisartan 80 mg monotherapy at the final visit (Visit 6) of the 502.261 study
- Patients who are able to provide written informed consent
- Patients who are able to enter the study immediately upon their completion of the preceding double-blind trial of the fixed dose combination (502.261)
Who cannot join
- Patients with any exclusion criterion (except criteria 1, 19 and 20), as defined in the preceding study (502.261):
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening)
- who are not surgically sterile (hysterectomy, tubal ligation)
- who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device (IUD), oral, implantable or injectable contraceptives
- Any women:
- who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 4)
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- who has a positive urine pregnancy test prior to taking the first dose of open-label medication (at Visit 2)
- who is nursing
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT (ALT) (serum glutamate pyruvate transaminase) or SGOT (AST) (serum glutamate oxaloacetate transaminase) greater than two times the upper limit of normal
- Serum creatinine > 2.3 mg/dL
- Clinically relevant sodium depletion, hyperkalemia, or hypokalemia at baseline
- Known or suspected secondary hypertension
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
- Congestive heart failure (CHF) (NYHA (New York Heart Association) class CHF III-IV)
- Unstable angina within the past three months
- Stroke within the past six months
- Myocardial infarction or cardiac surgery within the past three months
- PTCA (percutaneous transluminal coronary angioplasty) within the past three months
- History of angioedema
- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
- Administration of digoxin or other digitalis-type drugs
- Patients with insulin treated Type II diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥ 10%
- Known drug or alcohol dependency within the past one year period
- Known hypersensitivity to any component of the formulations
- Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of trial medication
About this study
Official title: An Open-Label, Six Month Safety Evaluation of the Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Mild-to-Moderate Hypertension
Study to assess the safety of six month of open-label, treatment with the fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients with mild-to-moderate hypertension who completed the eight week randomized, double blind 502.261 study.
- 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.
Telmisartan/hydrochlorothiazideDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan + Hydrochlorothiazide | Experimental | Not described Receives: Drug: Telmisartan/hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: up to 6 months
Changes from baseline in laboratory tests
Measured: Baseline and month 6
Changes from baseline in physical examination
Measured: Baseline and month 6
Changes from baseline in 12-lead ECG (electrocardiogram)
Measured: Baseline and month 6
Changes from baseline in seated blood pressure
Measured: Baseline, month 1, 3 and 6
Changes from baseline in pulse rate
Measured: Baseline, month 1, 3 and 6
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 1999
- Primary completionJan 2000
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT02177487
- Sponsor's protocol ID
- 502.321
- 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
- An Open-Label, Six Month Safety Evaluation of the Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Mild-to-Moderate Hypertension
- ClinicalTrials.gov ID
- NCT02177487
- Acronym / sponsor ID
- 502.321
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1999
- Primary completion
- Jan 2000 (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.
Study to assess the safety of six month of open-label, treatment with the fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients with mild-to-moderate hypertension who completed the eight week randomized, double blind 502.261 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telmisartan + Hydrochlorothiazide | Experimental | Drug: Telmisartan/hydrochlorothiazide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients who were randomized and completed all study visits of the preceding double-blind trial with the fixed dose combination (502.261) who meet the following criteria:
- Patients who are able to provide written informed consent
- Patients who are able to enter the study immediately upon their completion of the preceding double-blind trial of the fixed dose combination (502.261)
Key exclusion criteria (27 listed)
- Patients with any exclusion criterion (except criteria 1, 19 and 20), as defined in the preceding study (502.261):
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 |
|---|---|---|
| Telmisartan/hydrochlorothiazide | Drug | Telmisartan + Hydrochlorothiazide |
Primary outcome
Incidence of adverse events
Time frame: up to 6 months
Changes from baseline in laboratory tests
Time frame: Baseline and month 6
Changes from baseline in physical examination
Time frame: Baseline and month 6
Changes from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline and month 6
Changes from baseline in seated blood pressure
Time frame: Baseline, month 1, 3 and 6
Changes from baseline in pulse rate
Time frame: Baseline, month 1, 3 and 6
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.
- Related InfoLink provided by the sponsor.
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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/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 4 inclusion and 27 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?
Incidence of adverse events (time frame: up to 6 months). The study lists 6 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.