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NCT Number: NCT01392534

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

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.

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Key information

Conditions

Primary Hypertension Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)

Drug

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

Primary outcomes

  1. Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit

    Time frame: approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation

Secondary outcomes

  1. Change in plasma potassium between initial and final visit

    Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

  2. Change in fasting plasma glucose between initial and final visit

    Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

  3. Change in glycated haemoglobin A1C between initial and final visit

    Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

  4. Change in plasma high density lipoprotein between initial and (continued)

    Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

  5. Change in plasma low density lipoprotein between initial and final visit

    Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

  6. Change in plasma cholesterol between initial and final visit

    Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

  7. Change in plasma triglycerides between initial and final visit

    Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

  8. Adverse events collection

    Time frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: POTASSIUM

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 12, 2011
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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