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Trial record 42 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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 Type Observational
Study Design Time Perspective: Prospective
Condition Hypertension
Intervention Drug: Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Enrollment 2913
Recruitment Details April 1st 2009 to January 1st 2010 recruited in 90.5% General Practitioners (GP's) and 9.5% Specialists (Sp's)
Pre-assignment Details 45 patients excluded for inclusion/exclusion criteria
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 2913
Completed 2771
Not Completed 142
Reason Not Completed
Adverse Event             16
Lost to Follow-up             126
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 2913
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2913 participants
64.4  (12.6)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 2913 participants
Female 48.8
Male 51.2
Systolic and diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 2913 participants
Systolic Blood Pressure 156.1  (12.9)
Diastolic Blood Pressure 91.9  (8.64)
1.Primary Outcome
Title Percentage of Patients With Blood Pressure < 140/90 mm Hg
Hide Description % of high risk patients with Blood Pressure < 140/90 mm Hg
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2771
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
69.6
(67.9 to 71.3)
2.Secondary Outcome
Title Percentage of Patients With Blood Pressure < 130/80 mm Hg
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2771
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
13.2
(12.0 to 14.5)
3.Secondary Outcome
Title Absolute Blood Pressure Decrease
Hide Description systolic blood pressure
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2771
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
23.2
(22.7 to 23.7)
4.Secondary Outcome
Title BP Response Rate (Drop of Systolic BP of 10mmHg or More)
Hide Description BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2771
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
91.85
(90.8 to 92.6)
5.Secondary Outcome
Title Treatment Patterns
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2771
Measure Type: Number
Unit of Measure: Percentage of patients
Telmisartan 40mg 4.7
Telmisartan 80mg 49.4
Telmisartan 40/12,5mg 3.3
Telmisartan 80/12,5mg 29.7
Telmisartan 80/25mg 12.6
6.Secondary Outcome
Title Change in Concomitant Antihypertensive Drugs Given at Study Entry
Hide Description 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.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2771
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
13.6
(12.3 to 14.9)
7.Secondary Outcome
Title Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2771
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
11.7
(10.5 to 12.9)
8.Secondary Outcome
Title Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007
Hide Description 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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
all investigators participating in the trial
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 432
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of prescribers
47.7
(43 to 52.4)
Time Frame 12 weeks
Adverse Event Reporting Description solicited reporting
 
Arm/Group Title Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Affected / at Risk (%)
Total   3/2771 (0.11%) 
Gastrointestinal disorders   
Umbilical hernia  1  1/2771 (0.04%) 
Surgical and medical procedures   
Alcohol detoxification  1  1/2771 (0.04%) 
Vascular disorders   
cerebral hemorrhage, fatal  1  1/2771 (0.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Affected / at Risk (%)
Total   0/2771 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00890084    
Other Study ID Numbers: 502.581
First Submitted: April 28, 2009
First Posted: April 29, 2009
Results First Submitted: December 30, 2011
Results First Posted: May 2, 2012
Last Update Posted: April 8, 2014