HypertensionPhase 3NCT02177435
Telmisartan With or Without Hydrochlorothiazide in Patients With Mild-to-moderate Hypertension
A Phase 3 study testing Telmisartan and Telmisartan/Hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80) alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated trough diastolic blood pressure (DBP) after eight weeks… 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 and Telmisartan/Hydrochlorothiazide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 491 participants
- Where
- No sites listed yet
- Study dates
- Feb 1999to Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of mild-to-moderate hypertension
- Patients who fail to respond adequately to telmisartan monotherapy
- Participants between 18 and 80 years of age
- Ability to provide written informed consent
Who cannot join
- Patients taking more than three anti-hypertensive medications at the screening visit
- 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
- Any women:
- Who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 4)
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- 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
- Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
- Patients receiving any investigational therapy within one month of signing the informed consent form. Patients who have participated in previous telmisartan studies may participate in this study provided there has been at least one month between discontinuing the previous study and signing the consent for the present study
- 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 Eight Week Randomized, Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 80 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg.
Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80) alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated trough diastolic blood pressure (DBP) after eight weeks of treatment.
- Conditions
- Hypertension
- Being tested
- Telmisartan, Telmisartan/Hydrochlorothiazide, Placebo
- 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/HydrochlorothiazideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan plus Hydrochlorothiazide | Experimental | Not described Receives: Drug: Telmisartan/Hydrochlorothiazide; Drug: Placebo |
| Telmisartan | Experimental | Not described Receives: Drug: Telmisartan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in seated diastolic blood pressure (DBP) at trough
Measured: Baseline (day 0), day 28, day 56
Secondary outcomes (10)
Change from baseline in seated systolic blood pressure (SBP) at trough
Measured: Baseline (day 0), day 28, day 56
Change from baseline in standing DBP and SBP at trough
Measured: Baseline (day 0), day 28, day 56
Blood pressure control (seated DBP < 90 mmHg)
Measured: 16 weeks
Systolic blood pressure response
Measured: 16 weeks
Number of patients with abnormal findings in physical examination
Measured: Baseline (screening), day 0 and day 56
Changes from baseline in heart rate
Measured: Baseline (screening), day -56, -28, 0, 28 and 56
Number of patients with abnormal changes in laboratory parameters
Measured: Baseline (screening), day 0 and day 56
Number of patients with abnormal changes in resting 12-lead ECG (electrocardiogram)
Measured: Baseline (screening), day 0 and day 56
Orthostatic changes in blood pressure
Measured: Baseline (screening), day -56, -28, 0, 28 and 56
Number of patients with adverse events
Measured: up to 16 weeks
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 startFeb 1999
- Primary completionSep 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 491 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
- NCT02177435
- Sponsor's protocol ID
- 502.261
- 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 Eight Week Randomized, Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 80 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg.
- ClinicalTrials.gov ID
- NCT02177435
- Acronym / sponsor ID
- 502.261
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 1999
- Primary completion
- Sep 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.
Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80) alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated trough diastolic blood pressure (DBP) after eight weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan plus Hydrochlorothiazide | Experimental | Drug: Telmisartan/Hydrochlorothiazide, Drug: Placebo |
| Telmisartan | Experimental | Drug: Telmisartan, Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of mild-to-moderate hypertension
- Patients who fail to respond adequately to telmisartan monotherapy
- Participants between 18 and 80 years of age
- Ability to provide written informed consent
Key exclusion criteria (28 listed)
- Patients taking more than three anti-hypertensive medications at the screening visit
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening)
- Any women:
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- Clinically relevant sodium depletion, hyperkalemia, or hypokalemia at baseline
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 | Drug | Telmisartan |
| Telmisartan/Hydrochlorothiazide | Drug | Telmisartan plus Hydrochlorothiazide |
| Placebo | Drug | Telmisartan, Telmisartan plus Hydrochlorothiazide |
Primary outcome
Change from baseline in seated diastolic blood pressure (DBP) at trough
Time frame: Baseline (day 0), day 28, day 56
10 secondary outcomes
Change from baseline in seated systolic blood pressure (SBP) at trough
Time frame: Baseline (day 0), day 28, day 56
Change from baseline in standing DBP and SBP at trough
Time frame: Baseline (day 0), day 28, day 56
Blood pressure control (seated DBP < 90 mmHg)
Time frame: 16 weeks
Systolic blood pressure response
Time frame: 16 weeks
Number of patients with abnormal findings in physical examination
Time frame: Baseline (screening), day 0 and day 56
Changes from baseline in heart rate
Time frame: Baseline (screening), day -56, -28, 0, 28 and 56
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline (screening), day 0 and day 56
Number of patients with abnormal changes in resting 12-lead ECG (electrocardiogram)
Time frame: Baseline (screening), day 0 and day 56
Orthostatic changes in blood pressure
Time frame: Baseline (screening), day -56, -28, 0, 28 and 56
Number of patients with adverse events
Time frame: up to 16 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 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 and 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 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 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?
Change from baseline in seated diastolic blood pressure (DBP) at trough (time frame: Baseline (day 0), day 28, day 56). 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.