HypertensionPhase 3NCT00257491
Study to Evaluate the Trough and Peak Effect of Once Daily Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg (Micardis Plus) by Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Essential Hypertension
A Phase 3 study testing Telmisartan and Telmisartan/HCTZ in people with Hypertension, run by Boehringer Ingelheim at 1 site in China.
Trial summary
To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80 mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential hypertension. 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/HCTZ
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- Nov 2005to Aug 2006
- 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 essential hypertension defined by a mean seated DBP >= 95 and <= 109 mmHg, and SBP < 180mmHg measured by manual cuff sphygmomanometer at visit 2.
- Note: The manual cuff value is calculated as the mean of three seated measurements collected 2 minutes apart, after the patient has been seated quietly for 5 minutes. For calculation of mean values by the investigator, decimal places should be rounded to integers as usual (e.g., a DBP of 94.7 would be rounded to 95 mmHg and a DBP of 109.3 would be rounded to 109 mmHg).
- Participants between 18 and 80 years of age.
- Ability to provide written informed consent. 4.24 hour mean DBP >= 85 mmHg at visit 3.
- 5.Ability to stop any current antihypertensive therapy without risk to the patient (investigators discretion).
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. Acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives.
- Any woman:
- Who has a positive urine pregnancy test at screening (Visit 1).
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- Who is nursing.
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT(ALT) or SGOT(AST) greater than two times the upper limit of normal.
- Serum creatinine > 3.0 mg/dL (or 265 mmol/L) or creatinine clearance < 0.6 ml/sec.
- Clinically relevant hypokalaemia or hyperkalaemia.
- Uncorrected volume depletion.
- Uncorrected sodium depletion.
- Hereditary fructose intolerance.
- Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency.
- 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 (NYHA functional class CHF III-IV refer to Appendix 11. 1).
- Unstable angina within the past three months.
- Stroke within the past six months.
- Myocardial infarction or cardiac surgery within the past three months.
- PTCA within the past three months.
- Patients who have previously experienced symptoms characteristic of angiodema during treatment with ACE inhibitor or angiotensin II receptor antagonists.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study to Evaluate the Trough and Peak Effect of Once Daily Micardis Plus (Telmisartan 80mg / Hydrochlorothiazide 12.5 mg) by 24 ABPM in Patients With Mild to Moderate Essential Hypertension
To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80 mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential hypertension.
Read the detailed description
This study is designed as an open label study. After a 2-week placebo run-in phase, qualified patients will be administered with telmisartan 80mg for 2 weeks, then forcefully titrated to telmisartan 80 mg and hydrochlorothiazide 12.5 mg fixed dose combination for 6 weeks. 24 hour ABPM will be performed at the end of placebo run-in period (baseline) and after 8 weeks of active treatment.
Study Hypothesis:
The primary analyses will be the calculation of trough to peak ratios (T/P ratios) for DBP and SBP. The T/P ratio will be calculated on the basis of changes in hourly means (related to dosing time) from baseline (DeltaHM). Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. Thus, T/P is calculated as T/P = mean(DeltaHM22 - DeltaHM24)/min (DeltaHM2 - DeltaHM8).
Comparison(s):
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.
- Conditions
- Hypertension
- Being tested
- Telmisartan, Telmisartan/HCTZ
- 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/HCTZDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.
Secondary outcomes (1)
Smooth Index for DBP and SBP Change from the baseline in the ABPM endpoint: 24 hour mean, daytime mean , nighttime mean, morning mean, last 6-hours of the dosing interval mean SBP, DBP,MAP and HR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionAug 2006
- Study completionAug 2006
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257491
- Sponsor's protocol ID
- 502.488
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2005
- Last updated
- 11 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Trough and Peak Effect of Once Daily Micardis Plus (Telmisartan 80mg / Hydrochlorothiazide 12.5 mg) by 24 ABPM in Patients With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT00257491
- Acronym / sponsor ID
- 502.488
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006
- First posted
- 23 Nov 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.
To evaluate the trough and peak effect of once daily MICARDIS PLUS (Telmisartan 80 mg/hydrochlorothiazide 12.5 mg) by 24 ABPM in patients with mild to moderate essential hypertension.
Detailed description
This study is designed as an open label study. After a 2-week placebo run-in phase, qualified patients will be administered with telmisartan 80mg for 2 weeks, then forcefully titrated to telmisartan 80 mg and hydrochlorothiazide 12.5 mg fixed dose combination for 6 weeks. 24 hour ABPM will be performed at the end of placebo run-in period (baseline) and after 8 weeks of active treatment.
Study Hypothesis:
The primary analyses will be the calculation of trough to peak ratios (T/P ratios) for DBP and SBP. The T/P ratio will be calculated on the basis of changes in hourly means (related to dosing time) from baseline (DeltaHM). Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. Thus, T/P is calculated as T/P = mean(DeltaHM22 - DeltaHM24)/min (DeltaHM2 - DeltaHM8).
Comparison(s):
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of mild-to-moderate essential hypertension defined by a mean seated DBP >= 95 and <= 109 mmHg, and SBP < 180mmHg measured by manual cuff sphygmomanometer at visit 2.
- Note: The manual cuff value is calculated as the mean of three seated measurements collected 2 minutes apart, after the patient has been seated quietly for 5 minutes. For calculation of mean values by the investigator, decimal places should be rounded to integers as usual (e.g., a DBP of 94.7 would be rounded to 95 mmHg and a DBP of 109.3 would be rounded to 109 mmHg).
- Participants between 18 and 80 years of age.
- Ability to provide written informed consent. 4.24 hour mean DBP >= 85 mmHg at visit 3.
- 5.Ability to stop any current antihypertensive therapy without risk to the patient (investigators discretion).
Key exclusion criteria (25 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 woman:
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- Clinically relevant hypokalaemia or hyperkalaemia.
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/HCTZ | Drug | – |
Primary outcome
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.
1 secondary outcome
Smooth Index for DBP and SBP Change from the baseline in the ABPM endpoint: 24 hour mean, daytime mean , nighttime mean, morning mean, last 6-hours of the dosing interval mean SBP, DBP,MAP and HR.
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 11 Nov 2013.
- 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.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim Shanghai
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 and Telmisartan/HCTZ in people with Hypertension, run by Boehringer Ingelheim at 1 site in China.
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 25 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 11 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 China. 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?
To assess trough/peak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension.. 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 11 Nov 2013.