NCT01392534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,586

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

May 26, 2011

Last Update Submit

July 3, 2012

Conditions

Primary Hypertension

Keywords

HypertensionTelmisartanHydrochlorothiazidePotassiumGlucose metabolismLipid metabolism

Outcome Measures

Primary Outcomes (1)

  • Change in systolic (SBP) and diastolic (DBP) blood pressure between first and final visit

    approx. 3 mths after telmisartan/hydrochlorothiazide treatment initiation

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Group 1

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

Interventions

Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)DRUG

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

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • primary hypertension
  • age\>18 years

You may not qualify if:

  • Cholestatic disorders or severe hepatic/renal failure
  • allergy to telmisartan or hydrochlorothiazide
  • treatment-resistant hypokalemia or hypercalcemia
  • pregnancy and lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Poland

Location

MeSH Terms

Conditions

Essential HypertensionHypertension

Interventions

TelmisartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazides

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 26, 2011

First Posted

July 12, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

PL(1)