Trial Condition(s):

Primary Hypertension

Effects of telmisartan/hydrochlorothiazide treatment in hypertensive patients under real-life setting (POTASSIUM)

Bayer Identifier:

15297

ClinicalTrials.gov Identifier:

NCT01392534

EudraCT Number:

Not Available

Study Completed

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
1586
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Pritor Plus (Telmisartan/hydrochlorothiazide, BAY98-7103)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Poland

Status
Completed
 

Trial Design