Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness and Tolerability of Tarka® in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus (TARDIA)

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: NCT01079195
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Abbott

Study Type Observational
Condition Hypertension
Enrollment 15436
Recruitment Details  
Pre-assignment Details 15,873 participants enrolled in the study. Of these, documentation was available for 15,436 participants. 743 participants were excluded for the following reasons: No Tarka therapy documentation (739) and no follow-up data provided (4), leaving a study population of 14,693. No group assignments were made as the study design was observational.
Arm/Group Title Tarka Therapy
Hide Arm/Group Description Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
Period Title: Overall Study
Started 15873
Completed 14442
Not Completed 1431
Reason Not Completed
No Documentation of Tarka Therapy             739
No Documentation Available             437
Adverse Event             157
Reason Unknown             39
Withdrawal by Subject             18
Financial Reasons             15
Lack of Effectiveness             12
Physician Decision             4
Improved Status of Participant             4
No Follow-up Documentation Available             4
Non-compliance             2
Arm/Group Title Tarka Therapy
Hide Arm/Group Description Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
Overall Number of Baseline Participants 14693
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14693 participants
57.8  (11.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14693 participants
18 years of age or younger 2
Over 18 and less than 65 10565
65 and older 4085
Age not reported 41
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14693 participants
Female 7559
Male 7034
Gender not reported 100
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14693 participants
Bulgaria 309
Czech Republic 5643
Romania 1251
Russian Federation 2085
Slovakia 3179
Slovenia 1238
Ukraine 988
Time Since Diagnosis of Essential Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14693 participants
At study inclusion 249
Less than 1 year 108
Between 1 and 2 years 1536
Between 2 and 3 years 1573
Between 3 and 5 years 2482
Between 5 and 10 years 4187
10 years or more 4153
Time since diagnosis not reported 405
Risk Factors for Developing Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14693 participants
Positive Family History of Diabetes 2891
Obesity 3661
Impaired Fasting Glucose (IFG) 506
Positive Family History and Obesity 2983
Positive Family History and IFG 563
Obesity and IFG 1344
Positive Family History, Obesity, and IFG 1091
Diabetes 288
Risk factors not reported 1366
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 14693 participants
30.0  (4.8)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 14693 participants
87.1  (15.2)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 14693 participants
97.8  (13.1)
1.Primary Outcome
Title Reduction in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to Study End
Hide Description Participants were to be followed for 6 months. Changes in systolic and diastolic blood pressure were assessed by comparing the blood pressure measurements obtained at the end of Tarka treatment (approximately 6 months) to baseline values. For this analysis of effectiveness the last available value was considered the analysis time point "end of study".
Time Frame Baseline to 6 months/study end
Hide Outcome Measure Data
Hide Analysis Population Description
2122 participants were excluded from this analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).
Arm/Group Title Tarka Therapy
Hide Arm/Group Description:
Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
Overall Number of Participants Analyzed 12571
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic blood pressure change from baseline -28.5  (14.8)
Diastolic blood pressure change from baseline -16.1  (9.5)
2.Secondary Outcome
Title Percentage of Participants Achieving Target Blood Pressure (Less Than 140/90) at Study End and the Need for Other Antihypertensive Drugs, Clustered by Type(s) of Drugs Added to Tarka.
Hide Description The percentages of participants achieving and not achieving the target blood pressure of less than 140/90 mmHg at the end of the study are presented. Percentages of participants taking Tarka only or taking Tarka plus another antihypertensive drug are summarized by type of drug: beta blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists, diuretics, and angiotensin II (AT-II) receptor antagonists. Participants taking drugs that did not fit any of the above groups (Other), unknown drugs (Unknown), or more than one additional antihypertensive agent are also summarized.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
2122 participants were excluded from the analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).
Arm/Group Title Tarka Therapy
Hide Arm/Group Description:
Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
Overall Number of Participants Analyzed 12571
Measure Type: Number
Unit of Measure: Percentage of participants
Achieved target blood pressure 68.1
Did not achieve target blood pressure 31.9
Taking Tarka only 74.6
Taking Tarka and 1 antihypertensive drug 20.5
Taking Tarka and a beta blocking agent 1.1
Taking Tarka and an ACE-inhibitor 1.4
Taking Tarka and a calcium antagonist 0.9
Taking Tarka and a diuretic 10.7
Taking Tarka and an AT-II receptor antagonist 0.8
Taking Tarka and 1 Other antihypertensive drug 4.2
Taking Tarka and an Unknown antihypertensive drug 1.3
Taking Tarka and more than 1 antihypertensive drug 4.9
3.Secondary Outcome
Title Evaluation of Adverse Events (AEs) Leading to Discontinuation of Tarka and a Summary of All AEs Possibly or Probably Related to Tarka by Frequency and Severity
Hide Description The number of AEs leading to Tarka discontinuation are summarized. AEs that were considered by the investigator to be possibly or probably related to Tarka are summarized by the severity of the AE (classified as mild, moderate, or severe). AEs considered possibly or probably related to Tarka that led to the discontinuation of Tarka are also presented by severity.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis used the safety analysis population, which included any participant who took at least one dose of Tarka and had at least one follow-up visit.
Arm/Group Title Tarka Therapy
Hide Arm/Group Description:
Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
Overall Number of Participants Analyzed 14693
Measure Type: Number
Unit of Measure: Events
Any AE that led to discontinuation (d/c) of Tarka 224
AEs possibly or probably related to Tarka 199
a) Severity: Mild 107
b) Severity: Moderate 82
c) Severity: Severe 5
d) Severity: Unknown 5
Any AE possibly/probably related that led to d/c 171
a) Severity: Mild 85
b) Severity: Moderate 79
c) Severity: Severe 5
d) Severity: Unknown 2
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tarka Therapy
Hide Arm/Group Description Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
All-Cause Mortality
Tarka Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tarka Therapy
Affected / at Risk (%) # Events
Total   16/14693 (0.11%)    
Cardiac disorders   
Atrial fibrillation * 1  2/14693 (0.01%)  2
Cardiac failure * 1  1/14693 (0.01%)  1
Myocardial infarction * 1  2/14693 (0.01%)  2
Myocardial ischaemia * 1  1/14693 (0.01%)  1
General disorders   
Asthenia * 1  1/14693 (0.01%)  1
Death * 1  11/14693 (0.07%)  11
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer * 1  1/14693 (0.01%)  1
Non-Hodgkin's lymphoma * 1  1/14693 (0.01%)  1
Renal neoplasm * 1  1/14693 (0.01%)  1
Psychiatric disorders   
Alcohol abuse * 1  1/14693 (0.01%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism * 1  1/14693 (0.01%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Tarka Therapy
Affected / at Risk (%) # Events
Total   0/15873 (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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Responsible Party: Cornelia Preda MD/Medical Director Romania & Bulgaria, Abbott
ClinicalTrials.gov Identifier: NCT01079195     History of Changes
Other Study ID Numbers: P10-299
First Submitted: March 1, 2010
First Posted: March 3, 2010
Results First Submitted: March 4, 2011
Results First Posted: May 9, 2011
Last Update Posted: May 9, 2011