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

Completed

• Conditions: Primary Hypertension
• Interventions: Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)

• Registration Number: NCT01392534
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-03
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1586

Inclusion Criteria

• primary hypertension
• age>18 years

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Exclusion Criteria

• Cholestatic disorders or severe hepatic/renal failure
• allergy to telmisartan or hydrochlorothiazide
• treatment-resistant hypokalemia or hypercalcemia
• pregnancy and lactation period

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in plasma potassium between initial and final visit	approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation
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 low density lipoprotein 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