Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients

NCT01108809 | Completed Results

• 1 other identifier: 502.592
• Study Type: observational
• Target: 295
• Locations: 1 country
• Sites: 49

Brief Summary

The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risk scores. The study will also evaluate the current antihypertensive treatment pattern in the daily practice among the patient population at increased cardiovascular risk.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (5)

• Change in Systolic Blood Pressure From Baseline to Study End

  From baseline to visit 3 (6 months)

• Change in Diastolic Blood Pressure From Baseline to Study End

  From baseline to visit 3 (6 months)

• Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End

  A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

  From baseline to visit 3 (6 months)

• Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End

  10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

  From baseline to visit 3 (6 months)

• Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End

  ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

  From baseline to visit 3 (6 months)

Secondary Outcomes (5)

• Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)

  Visit 3 (6 months from baseline)

• Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)

  6 Months

• Change in Heart Rate From Baseline to Study End

  From baseline to visit 3 (6 months)

• Number of Participants Not Completing Study

  3rd visit (6 months)

• Number of Patients With Adverse Events (AE)

  6 months

Study Arms (1)

Patients with arterial hypertension

Drug: Telmisartan or Telmisartan and Hydrochlorthiazide

Interventions

Telmisartan or Telmisartan and Hydrochlorthiazide DRUG

Telmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg

Patients with arterial hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with arterial hypertension

You may qualify if:

• diagnosis of essential arterial hypertension (BP\>140/90 mm HG or BP\>130/80 mm Hg for diabetic patients)
• at least one additional cardiovascular risk factor and/or known single or multiple end organ damage and/or previous cardiovascular disease

You may not qualify if:

• hypersensitivity to the active substance or to any of the excipients in any ACE inhibitor or angiotensin receptor blocker (ARB) available on the local market, as prescribed in the SPC
• pregnancy and lactation
• diseases involving biliary obstruction
• severe liver impairment
• severe hypertension
• malignant hypertension
• secondary hypertension
• patients age under 18 years

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (49)

Boehringer Ingelheim Investigational Site 1

Arad, Romania

Location

Boehringer Ingelheim Investigational Site 5

Bacau, Romania

Location

Boehringer Ingelheim Investigational Site 6

Baia Mare, Romania

Location

Boehringer Ingelheim Investigational Site 9

Brasov, Romania

Location

Boehringer Ingelheim Investigational Site 8

Brăila, Romania

Location

Boehringer Ingelheim Investigational Site 10

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 11

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 12

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 13

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 14

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 15

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 16

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 17

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 18

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 19

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 20

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 21

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 22

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 23

Buzău, Romania

Location

Boehringer Ingelheim Investigational Site 4

Campulung Muscel, Romania

Location

Boehringer Ingelheim Investigational Site 42

Carei, Romania

Location

Boehringer Ingelheim Investigational Site 24

Călăraşi, Romania

Location

Boehringer Ingelheim Investigational Site 26

Cluj-Napoca, Romania

Location

Boehringer Ingelheim Investigational Site 27

Cluj-Napoca, Romania

Location

Boehringer Ingelheim Investigational Site 28

Cluj-Napoca, Romania

Location

Boehringer Ingelheim Investigational Site 29

Constanța, Romania

Location

Boehringer Ingelheim Investigational Site 31

Craiova, Romania

Location

Boehringer Ingelheim Investigational Site 2

Curtea de Argeş, Romania

Location

Boehringer Ingelheim Investigational Site 38

Drobeta-Turnu Severin, Romania

Location

Boehringer Ingelheim Investigational Site 32

Galati, Romania

Location

Boehringer Ingelheim Investigational Site 34

Iași, Romania

Location

Boehringer Ingelheim Investigational Site 35

Iași, Romania

Location

Boehringer Ingelheim Investigational Site 36

Iași, Romania

Location

Boehringer Ingelheim Investigational Site 37

Iași, Romania

Location

Boehringer Ingelheim Investigational Site 7

Oradea, Romania

Location

Boehringer Ingelheim Investigational Site 3

Piteşti, Romania

Location

Boehringer Ingelheim Investigational Site 40

Ploieşti, Romania

Location

Boehringer Ingelheim Investigational Site 41

Ploieşti, Romania

Location

Boehringer Ingelheim Investigational Site 49

Râmnicu Vâlcea, Romania

Location

Boehringer Ingelheim Investigational Site 25

Reşiţa, Romania

Location

Boehringer Ingelheim Investigational Site 33

Slobozia, Romania

Location

Boehringer Ingelheim Investigational Site 43

Suceava, Romania

Location

Boehringer Ingelheim Investigational Site 30

Târgovişte, Romania

Location

Boehringer Ingelheim Investigational Site 39

Târgu Mureş, Romania

Location

Boehringer Ingelheim Investigational Site 44

Timișoara, Romania

Location

Boehringer Ingelheim Investigational Site 45

Timișoara, Romania

Location

Boehringer Ingelheim Investigational Site 46

Timișoara, Romania

Location

Boehringer Ingelheim Investigational Site 47

Timișoara, Romania

Location

Boehringer Ingelheim Investigational Site 48

Tulcea, Romania

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 22, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2011
• Last Updated: March 28, 2014
• Results First Posted: September 24, 2012

Record last verified: 2014-02

Locations

RO (49)