Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telmisartan Tab Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00890084
Recruitment Status : Completed
First Posted : April 29, 2009
Results First Posted : May 2, 2012
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk

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

Detailed Description:
Study Design:
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 2913 participants
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.
Study Start Date : April 2009
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Group1 Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Telmisartan 40mg or 80mg +/- HCTZ 12.5mg or 25mg


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890084


Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00890084    
Other Study ID Numbers: 502.581
First Posted: April 29, 2009    Key Record Dates
Results First Posted: May 2, 2012
Last Update Posted: April 8, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Telmisartan
Telmisartan, hydrochlorothiazide drug combination
Antihypertensive Agents
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