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

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ClinicalTrials.gov Identifier: NCT01392534
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : July 4, 2012
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date May 26, 2011
First Posted Date July 12, 2011
Last Update Posted Date July 4, 2012
Study Start Date July 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2011)
Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit [ Time Frame: approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01392534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 11, 2011)
  • Change in plasma potassium between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ]
  • Change in fasting plasma glucose between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ]
  • Change in glycated haemoglobin A1C between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ]
  • Change in plasma high density lipoprotein between initial and (continued) [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ]
  • Change in plasma low density lipoprotein between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ]
  • Change in plasma cholesterol between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ]
  • Change in plasma triglycerides between initial and final visit [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ]
  • Adverse events collection [ Time Frame: approx 3 mths after telmisartan/hydrochlorothiazide treatment initiation ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting
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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Primary care clinic hypertensive patients not treated with telmisartan/hydrochlorothiazide for approx. 3 mths.
Condition Primary Hypertension
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
Study Groups/Cohorts Group 1
Intervention: Drug: Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 11, 2011)
1586
Original Actual Enrollment Same as current
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01392534
Other Study ID Numbers 15297
KL1010PL ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical Director, Bayer Sp. z o.o. , Poland
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date July 2012