Primary HypertensionPOTASSIUMNCT01392534
Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting
An observational study of Primary Hypertension, run by Bayer at 1 site in Poland.
Trial summary
One of the most common adverse effects resulting from the therapy with thiazides, thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of plasma potassium may be a life-threatening condition due to increased risk of arrythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)
- Type of treatment
- Pill or oral medicine
- How many people
- 1,586 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2010to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic hypertensive patients not treated with telmisartan/hydrochlorothiazide for approx. 3 mths.
Who may be able to join
- primary hypertension
- age>18 years
Who cannot join
- Cholestatic disorders or severe hepatic/renal failure
- allergy to telmisartan or hydrochlorothiazide
- treatment-resistant hypokalemia or hypercalcemia
- pregnancy and lactation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Real-life Efficacy and Safety of a Fixed-dose Telmisartan/Hydrochlorothiazide, Including Its Effect on Plasma Potassium and on Glucose and Lipid Metabolism Parameters in Patients With Essential Arterial Hypertension
One of the most common adverse effects resulting from the therapy with thiazides, thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of plasma potassium may be a life-threatening condition due to increased risk of arrythmias. Moreover, it has been postulated that decrease in plasma potassium level may negatively affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The main goal of this study is to assess the efficacy and safety of telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the effects of the therapy on plasma potassium level and also on selected parameters of glucose and lipid metabolism.
- Conditions
- Primary Hypertension
- Being tested
- Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)
- Keywords
- Hypertension, Telmisartan, Hydrochlorothiazide, Potassium, Glucose metabolism, Lipid metabolism
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)Drug
Patients treated with telmisartan/hydrochlorothiazide tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit
Measured: approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Secondary outcomes (8)
Change in plasma potassium between initial and final visit
Measured: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in fasting plasma glucose between initial and final visit
Measured: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in glycated haemoglobin A1C between initial and final visit
Measured: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma high density lipoprotein between initial and (continued)
Measured: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma low density lipoprotein between initial and final visit
Measured: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma cholesterol between initial and final visit
Measured: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma triglycerides between initial and final visit
Measured: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Adverse events collection
Measured: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- 1,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392534
- Sponsor's protocol ID
- 15297
- Other IDs
- KL1010PL
- Acronym
- POTASSIUM
- Status last verified
- Jul 2012
- First submitted
- 26 May 2011
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Real-life Efficacy and Safety of a Fixed-dose Telmisartan/Hydrochlorothiazide, Including Its Effect on Plasma Potassium and on Glucose and Lipid Metabolism Parameters in Patients With Essential Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01392534
- Acronym / sponsor ID
- POTASSIUM / 15297
- Conditions
- Primary Hypertension
- Keywords
- Hypertension, Telmisartan, Hydrochlorothiazide, Potassium, Glucose metabolism, Lipid metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,586 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Jul 2011 (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.
One of the most common adverse effects resulting from the therapy with thiazides, thiazide-like diuretics and loop diuretics is increased potassium secretion. Disregulation of plasma potassium may be a life-threatening condition due to increased risk of arrythmias. Moreover, it has been postulated that decrease in plasma potassium level may negatively affect glucose metabolism resulting in the increased risk of new-onset type 2 diabetes.The main goal of this study is to assess the efficacy and safety of telmisartan/hydrochlorothiazide in a broad population of hypertensive patients, including the effects of the therapy on plasma potassium level and also on selected parameters of glucose and lipid metabolism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic hypertensive patients not treated with telmisartan/hydrochlorothiazide for approx. 3 mths.
Key inclusion criteria (2 listed)
- primary hypertension
- age>18 years
Key exclusion criteria (4 listed)
- Cholestatic disorders or severe hepatic/renal failure
- allergy to telmisartan or hydrochlorothiazide
- treatment-resistant hypokalemia or hypercalcemia
- pregnancy and lactation period
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/hydrochlorothiazide (Pritor Plus, BAY98-7103)Patients treated with telmisartan/hydrochlorothiazide tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment | Drug | Group 1 |
Primary outcome
Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit
Time frame: approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation
8 secondary outcomes
Change in plasma potassium between initial and final visit
Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in fasting plasma glucose between initial and final visit
Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in glycated haemoglobin A1C between initial and final visit
Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma high density lipoprotein between initial and (continued)
Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma low density lipoprotein between initial and final visit
Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma cholesterol between initial and final visit
Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma triglycerides between initial and final visit
Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Adverse events collection
Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
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 4 Jul 2012.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hypertension, run by Bayer at 1 site in Poland.
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 2 inclusion and 4 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 4 Jul 2012. 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 Poland. 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?
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 in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit (time frame: approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation). 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 4 Jul 2012.