Trial Outcomes & Findings for A Blood Pressure Regulation and Stroke Risk Evaluation Study in Hypertensive Patients Treated With Eprosartan (NCT NCT01562613)

Last Updated: 2014-08-12

Results Overview

The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions. Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of \<140 mmHg/90 mmHg \[systolic BP (SBP)/diastolic BP (DBP)\] for the general population of hypertensive patients OR of \<130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions \[stroke, myocardial infarction, coronary artery disease (CAD)\]

Recruitment status

COMPLETED

Target enrollment

533 participants

Primary outcome timeframe

Baseline up to 6 months

Results posted on

2014-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Hypertensive Patients All eligible hypertensive patients treated with eprosartan
Overall Study STARTED	533
Overall Study COMPLETED	529
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Hypertensive Patients All eligible hypertensive patients treated with eprosartan
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Blood Pressure Regulation and Stroke Risk Evaluation Study in Hypertensive Patients Treated With Eprosartan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypertensive Patients n=533 Participants All eligible hypertensive patients treated with eprosartan
Age, Continuous	63.4 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	276 Participants n=5 Participants
Sex: Female, Male Male	257 Participants n=5 Participants
Region of Enrollment Greece	533 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months

Outcome measures

Outcome measures
Measure	Hypertensive Patients n=529 Participants All eligible hypertensive patients treated with eprosartan
The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions.	62.8 Percentage of participants Interval 58.6 to 66.9

PRIMARY outcome

Timeframe: Baseline up to 6 months

The absolute change in systolic Blood Pressure from baseline

Outcome measures

Outcome measures
Measure	Hypertensive Patients n=529 Participants All eligible hypertensive patients treated with eprosartan
The Absolute Change in Systolic Blood Pressure From Baseline	-31.1 mmHg Standard Deviation 11.9

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Excluded from Framingham calculation were patients with either 1. a history of cerebrovascular accident 2. any of the parameters missing for the calculation of the Framingham 3. age \<54 years or \> 84 years for females \& \<54 or \> 85 years for males

The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke. First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D'Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D'Agostino et al. The score can range from 0-38 (according to the scales of D' Agostino et al) with higher scores yielding increased 10-year probability of stroke.

Outcome measures

Outcome measures
Measure	Hypertensive Patients n=370 Participants All eligible hypertensive patients treated with eprosartan
Change in Framingham Stroke Risk Profile Scores of the Participating Patients Baseline	14 score on a scale Full Range 1.7 • Interval 4.0 to 29.0
Change in Framingham Stroke Risk Profile Scores of the Participating Patients 6 months	11 score on a scale Interval 3.0 to 27.0

Adverse Events

Hypertensive Patients

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hypertensive Patients n=533 participants at risk All eligible hypertensive patients treated with eprosartan
Infections and infestations Gastroenteritis	0.19% 1/533 • Number of events 1
Infections and infestations Respiratory tract infection	0.19% 1/533 • Number of events 1
Infections and infestations Urinary tract infection	0.19% 1/533 • Number of events 1
Cardiac disorders Dizziness	0.19% 1/533 • Number of events 1
Cardiac disorders Bradycardia	0.19% 1/533 • Number of events 1
Gastrointestinal disorders Gastritis	0.19% 1/533 • Number of events 1
Gastrointestinal disorders Gastrooesophageal reflux disease	0.19% 1/533 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	0.19% 1/533 • Number of events 1
Reproductive system and breast disorders Prostatitis	0.19% 1/533 • Number of events 1
Vascular disorders Hypotension	0.19% 1/533 • Number of events 1

Additional Information

Taco Baardman

Abbott

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60