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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01392534

Collaborator

(none)

1,586

Enrollment

Location

Duration (Months)

315.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hypertension	Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)

Study Design

Study Type:

Observational

Actual Enrollment :

1586 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Group 1	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

Arm

Intervention/Treatment

Group 1

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

Outcome Measures

Primary Outcome Measures

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

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]