HypertensionPhase 3NCT02177500
Telmisartan Plus Hydrochlorothiazide in Subjects With Mild-to-moderate Hypertension Who Failed to Respond to Telmisartan Monotherapy
A Phase 3 study testing Telmisartan + hydrochlorothiazide and Telmisartan in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic blood pressure in patients who fail to respond adequately to telmisartan monotherapy. 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 and Telmisartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to May 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
- History of mild-to-moderate hypertension
- Patients who fail to respond adequately to telmisartan monotherapy
- Participants between 18 and 80 years of age
- Willingness and ability to provide written informed consent
Who cannot join
- Patients taking more than three anti-hypertensive medications at the screening visit
- Pre-menopausal women
- Who are not surgically sterile
- 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 3)
Show all 28Show fewer
- Who is nursing
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters
- SGPT (serum glutamate pyruvate transaminase) or SGOT (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) functional 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 symptoms characteristic of angioedema during treatment with ACE inhibitors, angiotension II antagonists, thiazide diuretics, β-blockers or calcium channel blockers
- 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 Type I or 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 (except if they were on the fixed dose combination in the 502.261 study or enrolled in the 502.321 open-label extension study) 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 40 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 40 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 40 mg
An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic blood pressure in patients who fail to respond adequately to telmisartan monotherapy.
- Conditions
- Hypertension
- Being tested
- Telmisartan + hydrochlorothiazide, Telmisartan, Placebo
- 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
TelmisartanDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan + hydrochlorothiazide and matching placebo | Experimental | Not described Receives: Drug: Telmisartan + hydrochlorothiazide; Drug: Placebo |
| Telmisartan and matching placebo | 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)
Measured: baseline and after 8 weeks of treatment
Secondary outcomes (8)
Change from baseline in seated systolic blood pressure (SBP)
Measured: baseline and after 8 weeks of treatment
Blood pressure control
Measured: 8 weeks
Systolic blood pressure response
Measured: 8 weeks
Incidence of adverse events
Measured: up to 16 weeks
Change from baseline in physical examination
Measured: Baseline and day 56
Change from baseline in heart rate
Measured: Baseline, day 28 and 56
Change from baseline in laboratory parameters
Measured: Baseline and day 56
Change from baseline in 12-lead ECG (electrocardiogram)
Measured: Baseline and day 56
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 startJan 2000
- Primary completionMay 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 327 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
- NCT02177500
- Sponsor's protocol ID
- 502.323
- 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 40 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 40 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 40 mg
- ClinicalTrials.gov ID
- NCT02177500
- Acronym / sponsor ID
- 502.323
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- May 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.
An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic blood pressure in patients who fail to respond adequately to telmisartan monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan + hydrochlorothiazide and matching placebo | Experimental | Drug: Telmisartan + hydrochlorothiazide, Drug: Placebo |
| Telmisartan and matching placebo | 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
- Willingness and 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
- 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 + hydrochlorothiazide | Drug | Telmisartan + hydrochlorothiazide and matching placebo |
| Telmisartan | Drug | Telmisartan and matching placebo |
| Placebo | Drug | Telmisartan + hydrochlorothiazide and matching placebo, Telmisartan and matching placebo |
Primary outcome
Change from baseline in seated diastolic blood pressure (DBP)
Time frame: baseline and after 8 weeks of treatment
8 secondary outcomes
Change from baseline in seated systolic blood pressure (SBP)
Time frame: baseline and after 8 weeks of treatment
Blood pressure control
Time frame: 8 weeks
Systolic blood pressure response
Time frame: 8 weeks
Incidence of adverse events
Time frame: up to 16 weeks
Change from baseline in physical examination
Time frame: Baseline and day 56
Change from baseline in heart rate
Time frame: Baseline, day 28 and 56
Change from baseline in laboratory parameters
Time frame: Baseline and day 56
Change from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline and day 56
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.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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 and Telmisartan 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) (time frame: baseline and after 8 weeks 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 8 Jul 2014.