Trial Outcomes & Findings for Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With Tarka® Fixed Combination in Patients With Essential Hypertension (NCT NCT01127139)
NCT ID: NCT01127139
Last Updated: 2012-05-01
Results Overview
Participants were asked how many doses of Tarka they had missed after three months of treatment.
Recruitment status
COMPLETED
Target enrollment
3828 participants
Primary outcome timeframe
Month 3 Visit
Results posted on
2012-05-01
Participant Flow
Participant milestones
| Measure |
Czech Patients With Essential Hypertension
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
|
|---|---|
|
Overall Study
STARTED
|
3828
|
|
Overall Study
Number of Participants Analyzed
|
3828
|
|
Overall Study
COMPLETED
|
3771
|
|
Overall Study
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
Czech Patients With Essential Hypertension
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
|
|---|---|
|
Overall Study
Adverse Event
|
40
|
|
Overall Study
Incompliance
|
12
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Reason not specified
|
1
|
Baseline Characteristics
Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With Tarka® Fixed Combination in Patients With Essential Hypertension
Baseline characteristics by cohort
| Measure |
Czech Patients With Essential Hypertension
n=3828 Participants
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
|
|---|---|
|
Age, Customized
Age not reported
|
3828 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1943 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1885 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Month 3 VisitPopulation: All participants with evaluable case report forms were analyzed.
Participants were asked how many doses of Tarka they had missed after three months of treatment.
Outcome measures
| Measure |
Total
n=3828 Participants
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Female Participants
n=1943 Participants
Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Male Participants
n=1885 Participants
Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
|---|---|---|---|
|
Compliance With Tarka Treatment, All Participants and by Gender.
Missed one dose
|
1095 participants
|
548 participants
|
547 participants
|
|
Compliance With Tarka Treatment, All Participants and by Gender.
Never missed a dose
|
2190 participants
|
1141 participants
|
1049 participants
|
|
Compliance With Tarka Treatment, All Participants and by Gender.
Missed two doses
|
446 participants
|
213 participants
|
233 participants
|
|
Compliance With Tarka Treatment, All Participants and by Gender.
Missed more than 2 doses
|
82 participants
|
41 participants
|
56 participants
|
PRIMARY outcome
Timeframe: Month 6 VisitPopulation: All participants with evaluable case report forms were analyzed.
Participants were asked how many doses of Tarka they had missed since their previous visit.
Outcome measures
| Measure |
Total
n=3828 Participants
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Female Participants
n=1943 Participants
Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Male Participants
n=1885 Participants
Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
|---|---|---|---|
|
Compliance With Tarka Treatment, All Participants and by Gender.
Never missed a dose
|
2239 participants
|
1181 participants
|
1058 participants
|
|
Compliance With Tarka Treatment, All Participants and by Gender.
Missed one dose
|
901 participants
|
420 participants
|
481 participants
|
|
Compliance With Tarka Treatment, All Participants and by Gender.
Missed two doses
|
495 participants
|
253 participants
|
242 participants
|
|
Compliance With Tarka Treatment, All Participants and by Gender.
Missed more than 2 doses
|
193 participants
|
89 participants
|
104 participants
|
SECONDARY outcome
Timeframe: Baseline to Month 6 VisitPopulation: This analysis included all participants with complete data for the entire study.
The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit.
Outcome measures
| Measure |
Total
n=3783 Participants
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Female Participants
Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Male Participants
Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
|---|---|---|---|
|
Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change in systolic blood pressure
|
-28.28 mmHg
Standard Deviation 12.85
|
—
|
—
|
|
Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change in diastolic blood pressure
|
-16.39 mmHg
Standard Deviation 9.49
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 VisitPopulation: This analysis included all participants with complete data for the entire study.
The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment.
Outcome measures
| Measure |
Total
n=3783 Participants
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Female Participants
Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Male Participants
Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
|---|---|---|---|
|
Percentage of Patients Achieving Blood Pressure < 140/90 mmHg
|
44.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 6 VisitPopulation: This analysis included all participants with complete data for the entire study.
The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment.
Outcome measures
| Measure |
Total
n=3783 Participants
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Female Participants
Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Male Participants
Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
|---|---|---|---|
|
Percentage of Patients Achieving Blood Pressure < 140/90 mmHg
|
64.5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 VisitPopulation: This analysis included all participants with complete data for the entire study.
The number of participants at the Month 3 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach blood a pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.
Outcome measures
| Measure |
Total
n=3783 Participants
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Female Participants
Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Male Participants
Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
|---|---|---|---|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Central hypotensives
|
50 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Angiotensin receptor blockers
|
9 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Angiotensin receptor blocker + diuretic
|
2 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Angiotensin-converting enzyme (ACE) inhibitors
|
6 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Diuretic
|
84 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Combined diuretic
|
11 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Beta blocker
|
8 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Calcium channel blocker
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 6 VisitPopulation: This analysis included all participants with complete data for the entire study.
The number of participants at the Month 6 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach a blood pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.
Outcome measures
| Measure |
Total
n=3783 Participants
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Female Participants
Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Male Participants
Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
|---|---|---|---|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Central hypotensives
|
13 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Angiotensin receptor blockers
|
4 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Angiotensin receptor blocker + diuretic
|
2 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Angiotensin-converting enzyme (ACE) inhibitors
|
2 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Diuretic
|
23 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Combined diuretic
|
1 Participants
|
—
|
—
|
|
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
Beta blocker
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Month 6 VisitPopulation: All participants with case report forms were included in this analysis.
The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized.
Outcome measures
| Measure |
Total
n=3828 Participants
Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Female Participants
Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
Male Participants
Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
|
|---|---|---|---|
|
Adverse Events Leading to Study Discontinuation
> Stomach hyperacidity
|
1 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Night cough
|
1 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
Total discontinued study due to an adverse event
|
40 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Face oedema
|
1 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Nausea
|
2 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Tremor
|
1 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Dyspepsia
|
1 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Feet oedema
|
2 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Allergic reaction
|
1 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Constipation
|
6 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Dry cough
|
12 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Hypotension
|
3 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Intolerance
|
3 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Tachycardia
|
2 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Not specified
|
1 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Hypertension
|
1 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Constipation + dry cough + hair loss
|
1 Participants
|
—
|
—
|
|
Adverse Events Leading to Study Discontinuation
> Rash + palpitation
|
1 Participants
|
—
|
—
|
Adverse Events
Czech Patients With Essential Hypertension
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
Abbott
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER