Effects of Telmisartan/Hydrochlorothiazide Treatment in Hypertensive Patients Under Real-life Setting (POTASSIUM)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01392534
First received: May 26, 2011
Last updated: July 3, 2012
Last verified: July 2012
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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 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 Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Telmisartan Benzoates Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013