HypertensionPhase 3NCT00133185
A Randomized, Double-blind, Parallel-group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Moderate Hypertension
A Phase 3 study testing telmisartan 40 mg/hydrochlorothiazide 12.5 mg and losartan 50 mg/hydrochlorothiazide 12.5 mg in people with Hypertension, run by Boehringer Ingelheim at 1 site in Taiwan.
Trial summary
The primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- telmisartan 40 mg/hydrochlorothiazide 12.5 mg and losartan 50 mg/hydrochlorothiazide 12.5 mg
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2004to Mar 2005
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate hypertension as defined by a morning mean(>95 and <115mmHg) of two diastolic blood pressure measurements (DBP) after 5 min in the sitting position following a minimum 2-week placebo run in phase.Mean sitting systolic blood pressure (SBP) must be >140 and <200mmHg. The mean DBP and SBP values are calculated as the mean of the two sitting measurements taken 2 min apart just before the drug intake.
- Male or female between 20 to 80 years old
- Ability to provide written informed consent.
Who cannot join
- Patients are still taking more than three anti-hypertensives at the screening visit
- Pre-menopausal women
- Known or suspected secondary hypertension
- Mean sitting DBP<95mmHg and/or mean sitting SBP > 200mmHg at the end of placebo run-in phase
- Hepatic and/or renal dysfunction
- Known bilateral renal artery stenosis, patient with a solitary kidney, post renal transplant
Show all 21Show fewer
- Known NYHA functional class Chronic Heart Failure (CHF) III, IV
- Unstable angina, myocardial infarction, cardiac surgery or stroke within the preceding six months
- Post-Transluminal Coronary Angioplasty(PTCA) within the preceding three months
- Sustained ventricular tachycardia, atria fibrillation, second or third degree AV block, VPC or APC (>10% of heart rate) or other clinically relevant cardiac arrhythmia as determined by the clinical investigator
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
- Once documented evidence by ophthalmological examination of significant retinal haemorrhages/ exudates
- Clinically significant sodium depletion as defined by serum sodium level less than 130 mmol/L
- Clinically significant hyperkalemia as defined by serum potassium level >5.5 mmol/L
- Non-insulin dependent DM poorly controlled whicih is defined as HbA1c>8% twice consecutively within 6 months and/or AC blood sugar>180 mg/dl.
- Insulin Dependent Diabetes Mellitus
- Chronic administration of oral anticoagulants and/or digoxin within the past 6 months.
- Known drug or alcohol dependency
- Administration of medication known to affect blood pressure, except medication allowed by the protocol
- Angioedema with ACE inhibitors
- Use of nitrates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5 mg in Comparison With Losartan 50 mg Plus Hydrochlorothiazide 12.5 mg in Taiwanese Patients With Mild to Moderate Hypertension
The primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.
- Conditions
- Hypertension
- Being tested
- telmisartan 40 mg/hydrochlorothiazide 12.5 mg, losartan 50 mg/hydrochlorothiazide 12.5 mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartan 40 mg/hydrochlorothiazide 12.5 mgDrug
losartan 50 mg/hydrochlorothiazide 12.5 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase.
Measured: 8 weeks
Secondary outcomes (1)
Change from baseline in sitting SBP, standing DBP, standing SBP, sitting and standing heart rate at trough as well as blood pressure control and blood pressure response as defined in study protocol at the last observation will be evaluated.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startMar 2004
- Primary completionMar 2005
- Study completionMar 2005
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
- 31 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Taiwan Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133185
- Sponsor's protocol ID
- 502.406
- Status last verified
- Nov 2013
- First submitted
- 22 Aug 2005
- Last updated
- 19 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5 mg in Comparison With Losartan 50 mg Plus Hydrochlorothiazide 12.5 mg in Taiwanese Patients With Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT00133185
- Acronym / sponsor ID
- 502.406
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005
- First posted
- 23 Aug 2005 (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 is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate hypertension as defined by a morning mean(>95 and <115mmHg) of two diastolic blood pressure measurements (DBP) after 5 min in the sitting position following a minimum 2-week placebo run in phase.Mean sitting systolic blood pressure (SBP) must be >140 and <200mmHg. The mean DBP and SBP values are calculated as the mean of the two sitting measurements taken 2 min apart just before the drug intake.
- Male or female between 20 to 80 years old
- Ability to provide written informed consent.
Key exclusion criteria (21 listed)
- Patients are still taking more than three anti-hypertensives at the screening visit
- Pre-menopausal women
- Known or suspected secondary hypertension
- Mean sitting DBP<95mmHg and/or mean sitting SBP > 200mmHg at the end of placebo run-in phase
- Hepatic and/or renal dysfunction
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 40 mg/hydrochlorothiazide 12.5 mg | Drug | – |
| losartan 50 mg/hydrochlorothiazide 12.5 mg | Drug | – |
Primary outcome
Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase.
Time frame: 8 weeks
1 secondary outcome
Change from baseline in sitting SBP, standing DBP, standing SBP, sitting and standing heart rate at trough as well as blood pressure control and blood pressure response as defined in study protocol at the last observation will be evaluated.
Time frame: 8 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 19 Nov 2013.
- 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.
Boehringer Ingelheim Study Coordinator study chair
B.I. Taiwan Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing telmisartan 40 mg/hydrochlorothiazide 12.5 mg and losartan 50 mg/hydrochlorothiazide 12.5 mg in people with Hypertension, run by Boehringer Ingelheim at 1 site in Taiwan.
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 3 inclusion and 21 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 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase. (time frame: 8 weeks). 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 19 Nov 2013.