Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters

An observational study of Hypertension, run by Boehringer Ingelheim at 17 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this observational study is to survey the safety and effectiveness of the product under the real condition of usual practice in Taiwanese hypertensive patients. During the 8-week observation, the safety profiles and the clinical evaluation in between doses through blood pressure (BP) measurement for… Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypertension
How many people: 3,148 participants
Where: 17 sitesTaiwan
Study dates: Dec 2006to Dec 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Hypertension patients

Who may be able to join

1. Male or female. 2. Aged 20 to 80 years old. 3. Patients meet one of following two criteria:
Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic blood pressure (BP) > 140 mmHg but < 180 mmHg, and/or diastolic BP > 90 mmHg but < 110 mmHg).
Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.

Who cannot join

Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).
Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.
Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Taiwan17 sites

Boehringer Ingelheim Investigator Site
Changhua
Boehringer Ingelheim Investigator Site 1
Chiayi City
Boehringer Ingelheim Investigator Site 2
Chiayi City
Boehringer Ingelheim Investigator Site
Keelung
Boehringer Ingelheim Investigator Site
Ksohsiung
Boehringer Ingelheim Investigator Site
Miaoli
Boehringer Ingelheim Investigator Site 1
Taichung
Boehringer Ingelheim Investigator Site 2
Taichung
Boehringer Ingelheim Investigator Site 1
Tainan
Boehringer Ingelheim Investigator Site 2
Tainan
Boehringer Ingelheim Investigator Site 1
Taipei
Boehringer Ingelheim Investigator Site 2
Taipei
Boehringer Ingelheim Investigator Site 3
Taipei
Boehringer Ingelheim Investigator Site 4
Taipei
Boehringer Ingelheim Investigator Site 5
Taipei
Boehringer Ingelheim Investigator Site 6
Taipei
Boehringer Ingelheim Investigator Site 7
Taipei

Other trials in Taiwan

About this study

Official title: Safety and Effectiveness of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertension Patients

Conditions: Hypertension
Medical subject headings: Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Achieving Blood Pressure (BP) Control
BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.
Measured: 01-Dec-2006 to 31-Dec-2008

Secondary outcomes (3)

Percentage of Patients Achieving BP Response
Achieving BP response was defined as reduction from baseline in sitting SBP or DBP > 10 mmHg during the observational period. The observation period is 8 weeks.
Measured: 01-Dec-2006 to 31-Dec-2008
Overall Assessment by Patients
Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:
4: Outstanding 3: Very satisfactory 2: Satisfactory
1: Marginal 0: Not satisfactory
Measured: 01-Dec-2006 to 31-Dec-2008
Overall Assessment by Attending Physicians
Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:
4: Outstanding 3: Very satisfactory 2: Satisfactory
1: Marginal 0: Not satisfactory
Measured: 01-Dec-2006 to 31-Dec-2008

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Dec 2008

First posted14 Feb 2008 (estimated)
Study startDec 2006
Primary completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00615108
Sponsor's protocol ID: 502.519
Status last verified: Feb 2014
First submitted: 31 Jan 2008
Last updated: 7 Apr 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effectiveness of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertension Patients
ClinicalTrials.gov ID: NCT00615108
Acronym / sponsor ID: 502.519
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 3,148 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Dec 2008 (actual)
First posted: 14 Feb 2008 (estimated)
Results: Posted 26 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hypertension patients

Key inclusion criteria (3 listed)

1. Male or female. 2. Aged 20 to 80 years old. 3. Patients meet one of following two criteria:
Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic blood pressure (BP) > 140 mmHg but < 180 mmHg, and/or diastolic BP > 90 mmHg but < 110 mmHg).
Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.

Key exclusion criteria (3 listed)

Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).
Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.
Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Patients Achieving Blood Pressure (BP) Control
Time frame: 01-Dec-2006 to 31-Dec-2008
BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.

3 secondary outcomes

Percentage of Patients Achieving BP Response
Time frame: 01-Dec-2006 to 31-Dec-2008
Overall Assessment by Patients
Time frame: 01-Dec-2006 to 31-Dec-2008
Overall Assessment by Attending Physicians
Time frame: 01-Dec-2006 to 31-Dec-2008

Results and safety

Results posted to the registry on 26 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hypertension Patients	3,148	2,641

Primary outcome: Percentage of Patients Achieving Blood Pressure (BP) Control

Time frame: 01-Dec-2006 to 31-Dec-2008. Number. Unit: Percentage of Participants

Measure	Micardis 40mg n = 2406	Micardis 80mg n = 205	Total n = 2641
Value	66	46	65

Population analysed: Subjects include those who took 20mg, 40mg, 80mg and unknown dosage

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hypertension Patients	16 of 3,148 (0.5%)	0 of 3,148 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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 chair

Boehringer Ingelheim

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 17 sites 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 3 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 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Achieving Blood Pressure (BP) Control (time frame: 01-Dec-2006 to 31-Dec-2008). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00615108.

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 7 Apr 2014.