Clinical trial NCT01392534: Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hypertension
Keywords: Hypertension
Telmisartan
Hydrochlorothiazide
Potassium
Glucose metabolism
Lipid metabolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 1586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic hypertensive patients not treated with telmisartan/hydrochlorothiazide for approx. 3 mths.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* primary hypertension
* age\>18 years

Exclusion Criteria:

* Cholestatic disorders or severe hepatic/renal failure
* allergy to telmisartan or hydrochlorothiazide
* treatment-resistant hypokalemia or hypercalcemia
* pregnancy and lactation period

Primary outcomes:
measure: Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit
timeFrame: approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Secondary outcomes:
measure: Change in plasma potassium between initial and final visit
timeFrame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
measure: Change in fasting plasma glucose between initial and final visit
timeFrame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
measure: Change in glycated haemoglobin A1C between initial and final visit
timeFrame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
measure: Change in plasma high density lipoprotein between initial and (continued)
timeFrame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
measure: Change in plasma low density lipoprotein between initial and final visit
timeFrame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
measure: Change in plasma cholesterol between initial and final visit
timeFrame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
measure: Change in plasma triglycerides between initial and final visit
timeFrame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
measure: Adverse events collection
timeFrame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Other outcomes:
Locations:
city: Many Locations
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: