check_circleStudy Completed

Primary hypertension

Bayer Identifier:

15297

ClinicalTrials.gov Identifier:

NCT01392534

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

Both

Age

18 - N/A
  • - primary hypertension
    - age>18 years


  • - 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
1586
Trial Dates
July 2010 - December 2010
Phase
N/A
Could I Receive a placebo
No
Products
Pritor Plus (Telmisartan/hydrochlorothiazide, BAY98-7103)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland

Primary Outcome

  • Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit
    date_rangeTime Frame:
    approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in plasma potassium between initial and final visit
    date_rangeTime Frame:
    approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in fasting plasma glucose between initial and final visit
    date_rangeTime Frame:
    approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in glycated haemoglobin A1C between initial and final visit
    date_rangeTime Frame:
    approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in plasma high density lipoprotein between initial and (continued)
    date_rangeTime Frame:
    approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in plasma low density lipoprotein between initial and final visit
    date_rangeTime Frame:
    approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in plasma cholesterol between initial and final visit
    date_rangeTime Frame:
    approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in plasma triglycerides between initial and final visit
    date_rangeTime Frame:
    approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
    enhanced_encryption
    Safety Issue:
    Yes
  • Adverse events collection
    date_rangeTime Frame:
    approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

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