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

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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

Tracking Information
First Submitted Date March 1, 2010
First Posted Date March 3, 2010
Results First Submitted Date March 4, 2011
Results First Posted Date May 9, 2011
Last Update Posted Date May 9, 2011
Study Start Date October 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2011)
Reduction in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to Study End [ Time Frame: Baseline to 6 months/study end ]
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".
Original Primary Outcome Measures
 (submitted: March 2, 2010)
To determine the reduction of the systolic (SBP) and diastolic blood pressure (DBP) from baseline to study end while being treated with Tarka®. The reduction will be assessed by analyzing the changes of SBP and DB [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT01079195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 15, 2011)
  • 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. [ Time Frame: 6 months ]
    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.
  • 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 [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures
 (submitted: March 2, 2010)
  • The antihypertensive effectiveness of Tarka® will be assessed by: the percentage of patients achieving target BP levels (< 140/90) at the end of the study; the need for other antihypertensive drugs, clustered by type(s) of drugs added to Tarka [ Time Frame: 6 months ]
  • The tolerability of Tarka® will be assessed by: evaluation of adverse events leading to discontinuation of Tarka; summarizing of all adverse events related (probably and possibly) to Tarka® by frequency and severity [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effectiveness and Tolerability of Tarka® in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus
Official Title Effectiveness and Tolerability of Tarka in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus, Not Controlled on Single-drug Therapy: A Multicountry, Multicenter, Post-marketing Observational Study in the Routine Clinical Use
Brief Summary

The aim of this post-marketing observational study (PMOS) is to provide data on the effectiveness and tolerability of Tarka in patients with a high risk of developing diabetes mellitus, as prescribed by the physicians in a community setting and in accordance with the terms of the local marketing authorization. The following specific questions will be addressed:

  • Effectiveness of Tarka in lowering the blood pressure in hypertensive patients being at high risk of developing diabetes, not controlled on single-drug therapy.
  • Tolerability of Tarka as assessed by withdrawal rates.
Detailed Description

This is a non-interventional, observational, open-label, multicountry, multicenter post-marketing study in which Tarka is prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication. Patients with a high risk of developing diabetes mellitus treated by secondary care specialists (such as internal medicine specialists, nephrologists, endocrinologists, etc.), whose hypertension is not controlled on single-drug therapy will be included.

The assignment of the patient to the treatment with Tarka is not decided in advance by this protocol but falls within current practice. The prescription of Tarka is clearly separated from the decision to include the patient in this study. No additional procedures (other than standard of care) shall be applied to the patients.

Each patient will be treated at the physician's discretion. Dosing schedule should be in the accordance with the locally approved Summary of Product Characteristics (SmPC). Physicians will be provided with a study kit that includes a protocol, Tarka's locally approved SmPC, and case reports forms for each patient to be enrolled.

The patient's demographic data, height, weight and waist circumference will be reported in the Inclusion visit. The previous antihypertensive therapy should be noted (generic name of the drug and total daily dose). All other drugs the patient currently receives for cardiovascular disease treatment should be recorded as well.

The patient will then be followed via regular office visits as determined by the physician. As this study is observational in nature, patient follow-up is not interventional and is left to the judgment of each physician within the 6-month period, which defines the survey for each patient. For indicative purposes, follow-up of participant should enable 3 patient visits during this period. For these reasons, the most likely visits are defined as "Inclusion visit" at which treatment with Tarka is to be commenced, and then "Follow-up visit Month 3 " and "Follow-up visit Month 6", although dates will depend only on the decision of the physician. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a high risk of developing diabetes mellitus treated by secondary care specialists (such as internal medicine specialists, nephrologists, endocrinologists, etc.), whose hypertension is not controlled on single-drug therapy will be included.
Condition Hypertension
Intervention Not Provided
Study Groups/Cohorts Single Patient group with Hypertension
Single Patient group with Hypertension
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 15, 2011)
15436
Original Actual Enrollment
 (submitted: March 2, 2010)
15873
Actual Study Completion Date March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients of either gender (more than 18 years of age), with established diagnosis of essential hypertension (systolic blood pressure/ diastolic blood pressure greater than 140/90 mmHg)
  • Patients not controlled on single-drug therapy and decision was made to introduce Tarka
  • Patients with a high risk of developing diabetes mellitus (defined according British Medical Society guidelines) with at least one of the following symptoms:

    • Positive family history of diabetes or
    • Obesity defined by a Body Mass Index (BMI) greater than 30 kg/m^2 or a waist circumference greater than 102 cm (males) or greater than 88 cm (females) or
    • Impaired fasting plasma glucose (FPG) levels of 6.1 to 7.0 mmol/l (100-126 mg/dl)

Exclusion Criteria:

  • Patients with known or established Type 2 diabetes mellitus
  • The use of Tarka is contraindicated in the following patients:

    • Hypersensitive to the active substances or to any of the inactive ingredients
    • With cardiogenic shock
    • With second and third degree atrioventricular block - except in patients with a functioning artificial pacemaker
    • With sick sinus syndrome - except in patients with a functioning artificial pacemaker
    • With atrial fibrillation/flutter and concomitant Wolff-Parkinson-White syndrome
    • With existing history of angioedema associated with administration of an angiotensin-converting enzyme (ACE) inhibitor
    • With severe renal or severe liver impairment
    • In pregnant women (women of childbearing potential who are unwilling to use contraception should not be included)
    • Lactating women
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bulgaria,   Czech Republic,   Romania,   Russian Federation,   Slovakia,   Slovenia,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number NCT01079195
Other Study ID Numbers P10-299
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cornelia Preda MD/Medical Director Romania & Bulgaria, Abbott
Study Sponsor Abbott
Collaborators Not Provided
Investigators
Study Director: Cornelia Preda, MD Abbott International
PRS Account Abbott
Verification Date April 2011