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Trial record 43 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

An Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With 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: NCT00904215
Recruitment Status : Completed
First Posted : May 19, 2009
Results First Posted : August 31, 2009
Last Update Posted : April 21, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Time Perspective: Prospective
Condition Hypertension
Intervention Drug: telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)
Enrollment 1095
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Micardis/Micardis Plus
Hide Arm/Group Description Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
Period Title: Overall Study
Started 1095
Completed 960
Not Completed 135
Reason Not Completed
Adverse Event             25
Protocol Violation             10
Lost to Follow-up             63
Withdrawal by Subject             9
Other             28
Arm/Group Title Micardis/Micardis Plus
Hide Arm/Group Description Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
Overall Number of Baseline Participants 1025
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1025 participants
57  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1025 participants
Female
494
  48.2%
Male
531
  51.8%
1.Primary Outcome
Title Change in SBP (Systolic Blood Pressure)
Hide Description The change of the mean SBP
Time Frame between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
In clinical report form (CRF), some patients' SBP was not recorded.
Arm/Group Title Micardis/Micardis Plus
Hide Arm/Group Description:
Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
Overall Number of Participants Analyzed 958
Mean (Standard Deviation)
Unit of Measure: mmHg
-18  (19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Micardis/Micardis Plus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Student Paired t-test
Comments [Not Specified]
2.Primary Outcome
Title Change in DBP (Diastolic Blood Pressure)
Hide Description The change of the mean DBP
Time Frame between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis/Micardis Plus
Hide Arm/Group Description:
Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
Overall Number of Participants Analyzed 958
Mean (Standard Deviation)
Unit of Measure: mmHg
-10  (12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Micardis/Micardis Plus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Student Paired t-test
Comments [Not Specified]
3.Primary Outcome
Title Change in WHO-QOL (WHO-Quality Of Life)
Hide Description

World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed.

Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)

Time Frame between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis/Micardis Plus
Hide Arm/Group Description:
Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
Overall Number of Participants Analyzed 956
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.5  (7.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Micardis/Micardis Plus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Student Paired t-test
Comments [Not Specified]
4.Secondary Outcome
Title Change in VAS (Visual Analog Scale)
Hide Description VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)
Time Frame between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis/Micardis Plus
Hide Arm/Group Description:
Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
Overall Number of Participants Analyzed 918
Mean (Standard Deviation)
Unit of Measure: Units on a scale
5.9  (14.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Micardis/Micardis Plus
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Student Paired t-test
Comments [Not Specified]
Time Frame After signing informed consent through the end of study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Micardis/Micardis Plus
Hide Arm/Group Description Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
All-Cause Mortality
Micardis/Micardis Plus
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Micardis/Micardis Plus
Affected / at Risk (%)
Total   8 
Cardiac disorders   
Angina pectoris  1  1/1095 (0.09%) 
Angina unstable  1  1/1095 (0.09%) 
Gastrointestinal disorders   
Peritonitis  1  1/1095 (0.09%) 
Gastric polyps  1  1/1095 (0.09%) 
Gastric ulcer  1  1/1095 (0.09%) 
Gastrooesophageal reflux disease  1  1/1095 (0.09%) 
Varices oesophageal  1  1/1095 (0.09%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/1095 (0.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  1/1095 (0.09%) 
Nervous system disorders   
Cerebral infarction  1  1/1095 (0.09%) 
Vascular disorders   
Hypertension  1  1/1095 (0.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Micardis/Micardis Plus
Affected / at Risk (%)
Total   0/1095 (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.
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 Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00904215     History of Changes
Other Study ID Numbers: 502.487
First Submitted: May 18, 2009
First Posted: May 19, 2009
Results First Submitted: May 22, 2009
Results First Posted: August 31, 2009
Last Update Posted: April 21, 2014