Trial Condition(s):
Primary Hypertension
Effects of telmisartan/hydrochlorothiazide treatment in hypertensive patients under real-life setting (POTASSIUM)
Bayer Identifier:
15297
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visitTimeframe: approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Secondary Outcome
- Change in plasma potassium between initial and final visitTimeframe: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
- Change in fasting plasma glucose between initial and final visitTimeframe: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
- Change in glycated haemoglobin A1C between initial and final visitTimeframe: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
- Change in plasma high density lipoprotein between initial and (continued)Timeframe: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
- Change in plasma low density lipoprotein between initial and final visitTimeframe: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
- Change in plasma cholesterol between initial and final visitTimeframe: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
- Change in plasma triglycerides between initial and final visitTimeframe: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
- Adverse events collectionTimeframe: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Additional Information
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