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

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan or Telmisartan and Hydrochlorthiazide

• Registration Number: NCT01108809
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Primary Completion: 2011-01
• Results First Submitted: 2012-07-04
• Results First Submitted QC: 2012-09-21
• Results First Posted: 2012-09-24
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-28
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with arterial hypertension	Telmisartan or Telmisartan and Hydrochlorthiazide	-

Primary Outcome Measures

Name	Time	Method
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	From baseline to visit 3 (6 months)	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)
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End	From baseline to visit 3 (6 months)	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)
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End	From baseline to visit 3 (6 months)	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)
Change in Systolic Blood Pressure From Baseline to Study End	From baseline to visit 3 (6 months)

Secondary Outcome Measures

Name	Time	Method
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)	ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients
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 participants discontinuing study early for given reason
Number of Patients With Adverse Events (AE)	6 months

Trial Locations

Locations (49)

Boehringer Ingelheim Investigational Site 1; 🇷🇴 Arad, Romania

Boehringer Ingelheim Investigational Site 5; 🇷🇴 Bacau, Romania

Boehringer Ingelheim Investigational Site 6; 🇷🇴 Baia Mare, Romania

Boehringer Ingelheim Investigational Site 8; 🇷🇴 Braila, Romania

Boehringer Ingelheim Investigational Site 9; 🇷🇴 Brasov, Romania

Boehringer Ingelheim Investigational Site 10; 🇷🇴 Bucuresti, Romania

Boehringer Ingelheim Investigational Site 11; 🇷🇴 Bucuresti, Romania

Boehringer Ingelheim Investigational Site 12; 🇷🇴 Bucuresti, Romania

Boehringer Ingelheim Investigational Site 13; 🇷🇴 Bucuresti, Romania

Boehringer Ingelheim Investigational Site 14; 🇷🇴 Bucuresti, Romania

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