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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01392534
First received: May 26, 2011
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit [ Time Frame: approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in plasma potassium between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ] [ Designated as safety issue: Yes ]
  • Change in fasting plasma glucose between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ] [ Designated as safety issue: Yes ]
  • Change in glycated haemoglobin A1C between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ] [ Designated as safety issue: Yes ]
  • Change in plasma high density lipoprotein between initial and (continued) [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ] [ Designated as safety issue: Yes ]
  • Change in plasma low density lipoprotein between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ] [ Designated as safety issue: Yes ]
  • Change in plasma cholesterol between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ] [ Designated as safety issue: Yes ]
  • Change in plasma triglycerides between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ] [ Designated as safety issue: Yes ]
  • Adverse events collection [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ] [ Designated as safety issue: Yes ]

Enrollment: 1586
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic hypertensive patients not treated with telmisartan/hydrochlorothiazide for approx. 3 mths.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392534

Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Sp. z o.o. , Poland
ClinicalTrials.gov Identifier: NCT01392534     History of Changes
Other Study ID Numbers: 15297, KL1010PL
Study First Received: May 26, 2011
Last Updated: July 3, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Hypertension
Telmisartan
Hydrochlorothiazide
Potassium
Glucose metabolism
Lipid metabolism

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Hydrochlorothiazide
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014