Telmisartan Tab Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00890084
First received: April 28, 2009
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Hypertension
Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Patients With Blood Pressure < 140/90 mm Hg [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    % of high risk patients with Blood Pressure < 140/90 mm Hg


Secondary Outcome Measures:
  • Percentage of Patients With Blood Pressure < 130/80 mm Hg [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Absolute Blood Pressure Decrease [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    systolic blood pressure

  • BP Response Rate (Drop of Systolic BP of 10mmHg or More) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)

  • Treatment Patterns [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Change in Concomitant Antihypertensive Drugs Given at Study Entry [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 2913
Study Start Date: April 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group1 Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Telmisartan 40mg or 80mg +/- HCTZ 12.5mg or 25mg

Detailed Description:

Study Design:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890084

Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00890084     History of Changes
Other Study ID Numbers: 502.581
Study First Received: April 28, 2009
Results First Received: December 30, 2011
Last Updated: February 28, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Telmisartan
Telmisartan, hydrochlorothiazide drug combination
Benzoates
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 20, 2014