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OpenTrials
Completed

NCT Number: NCT00890084

Telmisartan Tab Hypertension

To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk

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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

About this study

Study Design:

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Hypertensive patients with BP. 140/90mmHgand high and very high cardiovascular risk according to the ESH/ESC Guidelines 2007 and in whom the prescriber has taken the decision to start treatment with telmisartan 40 or 80 mg, with or without HCTZ 12.5 mg or 25 mg, in the usual way and in line with the SmPC and reimbursement criteria

Exclusion criteria

Contra-indications as in the Summary of Product Characteristics

Treatment and study plan

Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)

Drug

Telmisartan 40mg or 80mg +/- HCTZ 12.5mg or 25mg

Primary outcomes

  1. Percentage of Patients With Blood Pressure < 140/90 mm Hg

    Time frame: 12 weeks

    % of high risk patients with Blood Pressure < 140/90 mm Hg

Secondary outcomes

  1. Percentage of Patients With Blood Pressure < 130/80 mm Hg

    Time frame: 12 weeks

  2. Absolute Blood Pressure Decrease

    Time frame: baseline and 12 weeks

    systolic blood pressure

  3. BP Response Rate (Drop of Systolic BP of 10mmHg or More)

    Time frame: 12 weeks

    BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)

  4. Treatment Patterns

    Time frame: 12 weeks

    Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications).

  5. Change in Concomitant Antihypertensive Drugs Given at Study Entry

    Time frame: baseline and 12 weeks

    Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not.

  6. Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg

    Time frame: 12 weeks

  7. Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007

    Time frame: 12 weeks

    Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

RESPECT: Observational, Prospective, Open-label, Multi-center Study Evaluating the Antihypertensive Effect of Treatment With Telmisartan (Alone or in Fixed Combination With HCTZ) in General Practitioner and Specialist Practice in Hypertensive Patients With High and Very High Cardiovascular Risk According to the ESH/ESC Guidelines 2007 Who Are Uncontrolled Under Current Treatment.

Important dates

Study start
2009
Primary completion
2009
First posted
Apr 29, 2009
Registry last updated
Apr 8, 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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