check_circleStudy Completed
Primary hypertension
Bayer Identifier:
15297
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Effects of telmisartan/hydrochlorothiazide treatment in hypertensive patients under real-life setting
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
1586Trial Dates
July 2010 - December 2010Phase
N/ACould I Receive a placebo
NoProducts
Pritor Plus (Telmisartan/hydrochlorothiazide, BAY98-7103)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Poland |
Primary Outcome
- Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visitdate_rangeTime Frame:approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiationenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in plasma potassium between initial and final visitdate_rangeTime Frame:approx 3 mths after telmisartan/hydrochlorothiazide treatment initiationenhanced_encryptionYesSafety Issue:
- Change in fasting plasma glucose between initial and final visitdate_rangeTime Frame:approx 3 mths after telmisartan/hydrochlorothiazide treatment initiationenhanced_encryptionYesSafety Issue:
- Change in glycated haemoglobin A1C between initial and final visitdate_rangeTime Frame:approx 3 mths after telmisartan/hydrochlorothiazide treatment initiationenhanced_encryptionYesSafety Issue:
- Change in plasma high density lipoprotein between initial and (continued)date_rangeTime Frame:approx 3 mths after telmisartan/hydrochlorothiazide treatment initiationenhanced_encryptionYesSafety Issue:
- Change in plasma low density lipoprotein between initial and final visitdate_rangeTime Frame:approx 3 mths after telmisartan/hydrochlorothiazide treatment initiationenhanced_encryptionYesSafety Issue:
- Change in plasma cholesterol between initial and final visitdate_rangeTime Frame:approx 3 mths after telmisartan/hydrochlorothiazide treatment initiationenhanced_encryptionYesSafety Issue:
- Change in plasma triglycerides between initial and final visitdate_rangeTime Frame:approx 3 mths after telmisartan/hydrochlorothiazide treatment initiationenhanced_encryptionYesSafety Issue:
- Adverse events collectiondate_rangeTime Frame:approx 3 mths after telmisartan/hydrochlorothiazide treatment initiationenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A