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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Hypertension

Intervention: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit

Secondary outcome:

Change in plasma potassium between initial and final visit

Change in fasting plasma glucose between initial and final visit

Change in glycated haemoglobin A1C between initial and final visit

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

Change in plasma low density lipoprotein between initial and final visit

Change in plasma cholesterol between initial and final visit

Change in plasma triglycerides between initial and final visit

Adverse events collection

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Many Locations, Poland
Additional Information

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Starting date: July 2010
Last updated: July 3, 2012

Page last updated: August 23, 2015

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