Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01392534

Acronym

POTASSIUM

Enrollment

1586

Registered

2011-07-12

Start date

2010-07-31

Completion date

2010-12-31

Last updated

2012-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypertension

Keywords

Hypertension, Telmisartan, Hydrochlorothiazide, Potassium, Glucose metabolism, Lipid metabolism

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.

Interventions

DRUGTelmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)

Patients treated with telmisartan/hydrochlorothiazide tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit	approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation

Secondary

Measure	Time frame
Change in fasting plasma glucose between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in glycated haemoglobin A1C between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma high density lipoprotein between initial and (continued)	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma potassium between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma cholesterol between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma triglycerides between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Adverse events collection	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
Change in plasma low density lipoprotein between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026