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NCT01392534 Clinical Trial

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

Primary Hypertension Clinical Trial

— POTASSIUM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01392534
Other study ID # 15297
Secondary ID KL1010PL
Status Completed
Phase N/A
First received May 26, 2011
Last updated July 3, 2012
Start date July 2010
Est. completion date December 2010

Study information
Verified date July 2012
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1586
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Telmisartan/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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation No
Secondary Change in plasma potassium between initial and final visit approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation Yes
Secondary Change in fasting plasma glucose between initial and final visit approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation Yes
Secondary Change in glycated haemoglobin A1C between initial and final visit approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation Yes
Secondary Change in plasma high density lipoprotein between initial and (continued) approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation Yes
Secondary Change in plasma low density lipoprotein between initial and final visit approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation Yes
Secondary Change in plasma cholesterol between initial and final visit approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation Yes
Secondary Change in plasma triglycerides between initial and final visit approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation Yes
Secondary Adverse events collection approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation Yes
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