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NCT Number: NCT00909038

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigator site 1, Ablon-sur-Seine, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypertensives
  • Treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg

Exclusion criteria

  • Treated with the combination less than 8 weeks

Treatment and study plan

Primary outcomes

  1. Rate of BP Control in Hypertensive Patients

    Time frame: 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 outcomes

  1. Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population

    Time frame: baseline to a minimum of 8 weeks of treatment

    Mean SBP measured at the Study End

  2. Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population

    Time frame: baseline to a minimum of 8 weeks of treatment

    Mean DBP measured at the Study End

  3. Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk

    Time frame: baseline to a minimum of 8 weeks of treatment

    Mean SBP measured at the Study End

  4. Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk

    Time frame: baseline to a minimum of 8 weeks of treatment

    Mean DBP measured at the Study End

  5. Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Descriptive Pharmaco-epidemiological Study of a Hypertensive Patient Population Treated With a Fixed-dose Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg and of Conditions for the Management of Arterial Hypertension

Important dates

Study start
2009
Primary completion
2009
First posted
May 27, 2009
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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