Telmisartan 80mg+Hydrochlorothiazide (HCTZ) 25 mg in Hypertension: an Observational Study

Completed

• Conditions: Hypertension

• Registration Number: NCT00909038
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

It is a national, retrospective , observational study in hypertensive patients treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg. The primary objective is to assess the control rate (systolic and diastolic blood pressure). Key secondary objectives are to assess the blood pressure reduction after at least 8 weeks of treatment, describe the population treated with this new fixed dose combination

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2009-11
• Results First Submitted: 2011-03-23
• Results First Submitted QC: 2011-03-23
• Results First Posted: 2011-04-14
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2411

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of BP Control in Hypertensive Patients	Baseline to a minimum of 8 weeks of treatment	Percentage of controlled Patients at the Study End.; Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) \<140/90 mmHg for unselected hypertensive patients and SBP and DBP \<130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines.

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population	baseline to a minimum of 8 weeks of treatment	Mean SBP measured at the Study End
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population	baseline to a minimum of 8 weeks of treatment	Mean DBP measured at the Study End
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk	baseline to a minimum of 8 weeks of treatment	Mean SBP measured at the Study End
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk	baseline to a minimum of 8 weeks of treatment	Mean DBP measured at the Study End
Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007	Baseline to a minimum of 8 weeks of treatment	The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.

Trial Locations

Locations (915)

Boehringer Ingelheim Investigator site 1; 🇫🇷 Ablon Sur Seine, France

Boehringer Ingelheim Investigator site 2; 🇫🇷 Achenheim, France

Boehringer Ingelheim Investigator site 3; 🇫🇷 Afa, France

Boehringer Ingelheim Investigator site 4; 🇫🇷 Aiguillon, France

Boehringer Ingelheim Investigator site 5; 🇫🇷 Aire Sur L Adour, France

Boehringer Ingelheim Investigator site 6; 🇫🇷 Aix En Othe, France

Boehringer Ingelheim Investigator site 7; 🇫🇷 Aix En Provence, France

Boehringer Ingelheim Investigator site 8; 🇫🇷 Aix En Provence, France

Boehringer Ingelheim Investigator site 9; 🇫🇷 Aix Les Bains, France

Boehringer Ingelheim Investigator site 10; 🇫🇷 Ajaccio, France

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