HypertensionPhase 3NCT02206659
Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) in Chinese Patients With Mild to Moderate Essential Hypertension
A Phase 3 study testing Telmisartan in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure monitoring in Chinese patients with mild to moderate essential hypertension Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Feb 2001
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese male or female aged 18 to 75 years
- Mild to moderate hypertension defined as a morning DBP _95 and <110 mm Hg at visit1 and visit 2. Mean sitting systolic pressure (SBP) must be <180 mm Hg
- Ability to provide written informed consent
Who cannot join
- Women who are pregnant or breast-feeding, or of childbearing potential without an effective method of birth control (effective birth control methods are: uterine device, surgical sterilisation, progestogens alone)
- Known or suspected secondary hypertension
- Known history of any chronic hepatic disease
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
- New York Heart Association (NYHA) functional class congestive heart failure (CHF) III-IV
- Unstable angina pectoris
Show all 19Show fewer
- Myocardial infarction or percutaneous transluminal coronary angiography (PTCA) or cardiac surgery within the preceding three months
- Clinical relevant cardiac arrhythmias as determined by the clinical investigator
- Hypertrophic obstructive cardiomyopathy or clinically significant valvular disease
- Evidence of retinal hemorrhages/exudates
- Clinical significant hyperkalemia as defined by serum potassium level >6.0 milliequivalents (mEq)/L
- Insulin-dependent diabetes mellitus
- Non-insulin-dependent diabetes mellitus with poor glucose control as defined by persistent fasting blood sugar >200 mg/dl, peripheral neuropathy or autonomic neuropathy
- Known drug or alcohol dependency
- Administration of any diuretic, ACE inhibitor or angiotensin II receptor antagonist within two weeks before run-in period
- Administration of medication known to affect blood pressure during trial period
- Patients receiving any investigational therapy within one month of signing the informed consent form
- Known hypersensitivity to any component of the formulation
- Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of trial medication
About this study
Official title: An Open-label Evaluation of Trough and Peak Effects of 40 mg Telmisartan Tablet by Ambulatory Blood Pressure Monitoring in Chinese Patients With Mild to Moderate Essential Hypertension
To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure monitoring in Chinese patients with mild to moderate essential hypertension
- Conditions
- Hypertension
- Being tested
- 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.
TelmisartanDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | 2-week placebo run-in period followed by 6 weeks of treatment with telmisartan Receives: Drug: Telmisartan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)
Measured: 42 days after start of treatment
Median of T/P ratio for DBP and SBP
Measured: 42 days after start of treatment
Secondary outcomes (4)
Change in mean 24-hr DBP and SBP
Measured: Day -13, 42 days after start of treatment
Change in daytime mean for SBP and DBP
Measured: Day -13, 42 days after start of treatment
Change in nighttime mean for SBP and DBP
Measured: Day -13, 42 days after start of treatment
Change in mean of DBP and SBP for last 6-hr dosing interval
Measured: Day -13, 42 days after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startAug 2000
- Primary completionFeb 2001
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02206659
- Sponsor's protocol ID
- 502.367
- Status last verified
- Jul 2014
- First submitted
- 31 Jul 2014
- Last updated
- 1 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Evaluation of Trough and Peak Effects of 40 mg Telmisartan Tablet by Ambulatory Blood Pressure Monitoring in Chinese Patients With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT02206659
- Acronym / sponsor ID
- 502.367
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Feb 2001 (actual)
- First posted
- 1 Aug 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.
To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure monitoring in Chinese patients with mild to moderate essential hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: Telmisartan, Drug: Placebo2-week placebo run-in period followed by 6 weeks of treatment with telmisartan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese male or female aged 18 to 75 years
- Mild to moderate hypertension defined as a morning DBP _95 and <110 mm Hg at visit1 and visit 2. Mean sitting systolic pressure (SBP) must be <180 mm Hg
- Ability to provide written informed consent
Key exclusion criteria (19 listed)
- Women who are pregnant or breast-feeding, or of childbearing potential without an effective method of birth control (effective birth control methods are: uterine device, surgical sterilisation, progestogens alone)
- Known or suspected secondary hypertension
- Known history of any chronic hepatic disease
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
- New York Heart Association (NYHA) functional class congestive heart failure (CHF) III-IV
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 |
| Placebo | Drug | Telmisartan |
Primary outcome
Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)
Time frame: 42 days after start of treatment
Median of T/P ratio for DBP and SBP
Time frame: 42 days after start of treatment
4 secondary outcomes
Change in mean 24-hr DBP and SBP
Time frame: Day -13, 42 days after start of treatment
Change in daytime mean for SBP and DBP
Time frame: Day -13, 42 days after start of treatment
Change in nighttime mean for SBP and DBP
Time frame: Day -13, 42 days after start of treatment
Change in mean of DBP and SBP for last 6-hr dosing interval
Time frame: Day -13, 42 days after start of treatment
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 1 Aug 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 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 3 inclusion and 19 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 1 Aug 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?
Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP) (time frame: 42 days after start of treatment). The study lists 2 primary outcomes in all. 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 1 Aug 2014.