HypertensionNCT02242396
A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® to Control the Early Morning BP Rise (SURGE II)
An observational study of Hypertension, run by Boehringer Ingelheim.
Trial summary
The primary objective was to evaluate, through the use of Home blood pressure monitoring (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide. 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 hydrochlorothiazide
- How many people
- 5,248 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Nov 2007
- Phase
- Observational
- 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
Study population: Hypertensive population under real life clinical practice in an ambulatory setting
Who may be able to join
- Patients male or female between 18 and 80 years of age
- Patients with mild to moderate essential hypertension
- Patients diagnosed with hypertension that are not currently taking antihypertensive medication or previously diagnosed hypertensive patients who are uncontrolled with their current treatment
Who cannot join
- Pre-menopausal women who have no birth control, who are pregnant or nursing
- Patients with advanced hepatic impairment or advanced renal impairment
- Patients with New York Heart Association (NYHA) functional class III or IV congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
- Patients with any type of relevant arrhythmia according to the assessment of the investigator
- Patients with any valvular disease with hemodynamic repercussion
- Patients receiving chronic administration of oral anticoagulants or digoxin
Show all 10Show fewer
- Patients with known hypersensitivity to any component in the formulation of Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide
- Patients with previous history of angioedema associated with angiotensin converting enzyme (ACE) inhibitors
- Patients with severe, uncontrolled hypertension or any form of secondary hypertension
- Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol
About this study
Official title: A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® Under Real Clinical Conditions With the Goal to Control the Early Morning BP Rise (SURGE II)
The primary objective was to evaluate, through the use of Home blood pressure monitoring (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.
The co-primary endpoints were the degree of BP control, and change from baseline until study end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.
Secondary endpoints were office BP control rates, office BP response rates, and reduction in mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit, discontinuations and tolerability
- Conditions
- Hypertension
- Being tested
- Telmisartan, Telmisartan hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Also called Micardis®
Telmisartan hydrochlorothiazideDrug
Also called Micardis Plus®
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive patients | Not described Receives: Drug: Telmisartan; Drug: Telmisartan hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of degree of Blood Pressure (BP) control in the early morning hours
Measured: 8 weeks of treatment
Change from baseline in mSBP and mDBP by HBPM in the early morning
BP control during the morning time-periods (6:00 to 11:59), BP < 135/85 mmHg (HBPM: mean of morning measurements)
Measured: Baseline, after 8 weeks of treatment
Secondary outcomes (6)
Change from baseline in office BP control rates
Measured: Baseline, after 8 weeks
Change from baseline in office BP response rates
Measured: Baseline, after 8 weeks
Reduction in mSBP and mDBP by OBPM
Measured: Baseline, after 8 weeks
Number of patients with adverse events
Measured: up to 8 weeks
Global Assessment of tolerability by investigator on a 6-point scale
Measured: after 8 weeks
Global assessment efficacy by investigator on 6-point scale
Measured: after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startAug 2005
- Primary completionNov 2007
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,248 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
- NCT02242396
- Sponsor's protocol ID
- 502.496
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of a Hypertensive Population Under Treatment With Micardis® and Micardis Plus® Under Real Clinical Conditions With the Goal to Control the Early Morning BP Rise (SURGE II)
- ClinicalTrials.gov ID
- NCT02242396
- Acronym / sponsor ID
- 502.496
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,248 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Nov 2007 (actual)
- First posted
- 17 Sep 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.
The primary objective was to evaluate, through the use of Home blood pressure monitoring (HBPM), the degree of BP control in the early morning hours after 8 weeks of treatment in patients with essential hypertension under treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.
The co-primary endpoints were the degree of BP control, and change from baseline until study end in mean systolic blood pressure (mSBP) and mean diastolic blood pressure (mDBP) HBPM in the early morning hours after 8 weeks of treatment with Micardis®, Telmisartan or Micardis Plus®, Telmisartan hydrochlorothiazide.
Secondary endpoints were office BP control rates, office BP response rates, and reduction in mSBP and mDBP Office blood pressure measurement (OBPM) from baseline to final visit, discontinuations and tolerability
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | – | Drug: Telmisartan, Drug: Telmisartan hydrochlorothiazide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive population under real life clinical practice in an ambulatory setting
Key inclusion criteria (3 listed)
- Patients male or female between 18 and 80 years of age
- Patients with mild to moderate essential hypertension
- Patients diagnosed with hypertension that are not currently taking antihypertensive medication or previously diagnosed hypertensive patients who are uncontrolled with their current treatment
Key exclusion criteria (10 listed)
- Pre-menopausal women who have no birth control, who are pregnant or nursing
- Patients with advanced hepatic impairment or advanced renal impairment
- Patients with New York Heart Association (NYHA) functional class III or IV congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
- Patients with any type of relevant arrhythmia according to the assessment of the investigator
- Patients with any valvular disease with hemodynamic repercussion
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 |
|---|---|---|
| TelmisartanAlso: Micardis® | Drug | Hypertensive patients |
| Telmisartan hydrochlorothiazideAlso: Micardis Plus® | Drug | Hypertensive patients |
Primary outcome
Change of degree of Blood Pressure (BP) control in the early morning hours
Time frame: 8 weeks of treatment
Change from baseline in mSBP and mDBP by HBPM in the early morning
Time frame: Baseline, after 8 weeks of treatment
BP control during the morning time-periods (6:00 to 11:59), BP < 135/85 mmHg (HBPM: mean of morning measurements)
6 secondary outcomes
Change from baseline in office BP control rates
Time frame: Baseline, after 8 weeks
Change from baseline in office BP response rates
Time frame: Baseline, after 8 weeks
Reduction in mSBP and mDBP by OBPM
Time frame: Baseline, after 8 weeks
Number of patients with adverse events
Time frame: up to 8 weeks
Global Assessment of tolerability by investigator on a 6-point scale
Time frame: after 8 weeks
Global assessment efficacy by investigator on 6-point scale
Time frame: after 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 17 Sep 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?
An observational study of 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 10 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 17 Sep 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.
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 of degree of Blood Pressure (BP) control in the early morning hours (time frame: 8 weeks 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 17 Sep 2014.