HypertensionPhase 3NCT02183701
Telmisartan Compared to Losartan + Hydrochlorothiazide in Patients With Mild-to-moderate Essential Hypertension
A Phase 3 study testing Telmisartan and Losartan + Hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
The general aim and clinical objective of this trial is to determine the effect of telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and… 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 Losartan + Hydrochlorothiazide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 715 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Dec 1998
- 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
- Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer, on Visit 2 of the four-week placebo run-in period (baseline)
- Mean seated systolic blood pressure ≥ 140 mmHg, measured by manual cuff at baseline (Visit 2)
- A 24-hour mean diastolic blood pressure , measured by ABPM, of ≥ 85 mmHg evaluated at baseline (Visit 3)
- Age 18 or older
- Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
Who cannot join
- Pre-menopausal women (last menstruation ≤ 1 year prior to date of consent):
- Who are not surgically sterile (hysterectomy, tubal ligation)
- Who are NOT practising acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the trial. Acceptable methods of birth control include IUD (intrauterine device), oral, implantable or injectable contraceptives
- Who have a positive urine pregnancy test
- Who are nursing
- Mean seated diastolic blood pressure (DBP) > 114 mmHg or mean seated systolic BP > 200 mmHg, by manual cuff
Show all 27Show fewer
- Any known hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT (serum glutamate pyruvate transaminase) (ALT) or SGOT (serum glutamate oxaloacetate transaminase) (AST) greater than two times the upper limit of normal
- Serum creatinine > 1.8 mg/dl (or 159 µmol/l)
- Clinically relevant hypokalemia
- Known or suspected secondary hypertension
- Known 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 3 months; stable angina where a change in nitrate therapy (dose or frequency) during the run-in period was required
- Stroke within the past 6 months prior to start of run-in period
- Myocardial infarction or cardiac surgery within the past 3 months prior to start of run-in period
- PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to start of run-in period
- Previous history of angioedema
- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
- Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
- Patients with unstable insulin-dependent diabetes mellitus (risk of hypoglycemia or HbA1c ≥ 10 % in history within 6 months prior to start of run-in period)
- Known drug or alcohol dependency within the past 6 months period prior to start of run-in 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
- 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
- Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)
About this study
Official title: A Prospective Randomised Open-Label Blinded Endpoint Trial Comparing Telmisartan 80 mg and Losartan 50 mg + Hydrochlorothiazide 12.5 mg (Fixed Dose Combination) in Patients With Mild-to-Moderate Essential Hypertension Using Ambulatory Blood Pressure Monitoring
The general aim and clinical objective of this trial is to determine the effect of telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff measurements at the end of the treatment.
- Conditions
- Hypertension
- Being tested
- Telmisartan, Losartan + 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
Losartan + HydrochlorothiazideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | 4 weeks placebo run-in, 6-weeks fixed dose period Receives: Drug: Telmisartan; Drug: Placebo |
| Losartan + Hydrochlorothiazide | Active comparator | 4 weeks placebo run-in, 6-weeks fixed dose period (Losartan 50 mg / HCTZ 12.5 mg) Receives: Drug: Losartan + Hydrochlorothiazide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM
Measured: Baseline (Day 28 of run-in period) and day 42
Secondary outcomes (8)
Change from baseline in 24-hour mean systolic blood pressure measured by ABPM
Measured: Baseline (Day 28 of run-in period) and day 42
Change from baseline in systolic and diastolic blood pressures during other time periods during the 24-hour ABPM profile
Measured: Baseline (Day 28 of run-in period) and day 42
Change from baseline (Visit 2) in trough systolic and diastolic blood pressures measured by cuff sphygmomanometer
Measured: Baseline (Day 28 of run-in period) and day 42
Number of patient with of adverse events
Measured: up to 10 weeks
Changes from baseline in pulse rate
Measured: Baseline (Day 28 of run-in period) and day 42
Changes in physical examination
Measured: Screening and day 43
Changes in laboratory parameters
Measured: Screening and day 43
Changes in 12-lead electrocardiogram (ECG)
Measured: Baseline (Day 29 of run-in period) and day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 1998
- Primary completionDec 1998
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
- None (open label)
- Enrolment
- 715 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
- NCT02183701
- Sponsor's protocol ID
- 502.257
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 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
- A Prospective Randomised Open-Label Blinded Endpoint Trial Comparing Telmisartan 80 mg and Losartan 50 mg + Hydrochlorothiazide 12.5 mg (Fixed Dose Combination) in Patients With Mild-to-Moderate Essential Hypertension Using Ambulatory Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT02183701
- Acronym / sponsor ID
- 502.257
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 8 Jul 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 general aim and clinical objective of this trial is to determine the effect of telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff measurements at the end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: Telmisartan, Drug: Placebo4 weeks placebo run-in, 6-weeks fixed dose period |
| Losartan + Hydrochlorothiazide | Active comparator | Drug: Losartan + Hydrochlorothiazide, Drug: Placebo4 weeks placebo run-in, 6-weeks fixed dose period (Losartan 50 mg / HCTZ 12.5 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer, on Visit 2 of the four-week placebo run-in period (baseline)
- Mean seated systolic blood pressure ≥ 140 mmHg, measured by manual cuff at baseline (Visit 2)
- A 24-hour mean diastolic blood pressure , measured by ABPM, of ≥ 85 mmHg evaluated at baseline (Visit 3)
- Age 18 or older
- Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
Key exclusion criteria (27 listed)
- Pre-menopausal women (last menstruation ≤ 1 year prior to date of consent):
- Mean seated diastolic blood pressure (DBP) > 114 mmHg or mean seated systolic BP > 200 mmHg, by manual cuff
- Any known hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- Clinically relevant hypokalemia
- Known or suspected secondary hypertension
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 |
| Losartan + Hydrochlorothiazide | Drug | Losartan + Hydrochlorothiazide |
| Placebo | Drug | Losartan + Hydrochlorothiazide, Telmisartan |
Primary outcome
Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM
Time frame: Baseline (Day 28 of run-in period) and day 42
8 secondary outcomes
Change from baseline in 24-hour mean systolic blood pressure measured by ABPM
Time frame: Baseline (Day 28 of run-in period) and day 42
Change from baseline in systolic and diastolic blood pressures during other time periods during the 24-hour ABPM profile
Time frame: Baseline (Day 28 of run-in period) and day 42
Change from baseline (Visit 2) in trough systolic and diastolic blood pressures measured by cuff sphygmomanometer
Time frame: Baseline (Day 28 of run-in period) and day 42
Number of patient with of adverse events
Time frame: up to 10 weeks
Changes from baseline in pulse rate
Time frame: Baseline (Day 28 of run-in period) and day 42
Changes in physical examination
Time frame: Screening and day 43
Changes in laboratory parameters
Time frame: Screening and day 43
Changes in 12-lead electrocardiogram (ECG)
Time frame: Baseline (Day 29 of run-in period) and day 43
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 Losartan + 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 5 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?
Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM (time frame: Baseline (Day 28 of run-in period) and day 42). 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.