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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01562613
• Collaborator: (none)
• Enrollment: 533
• Locations: 84
• Duration (Months): 12
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the proportion of hypertensive patients who achieve regulation of their blood pressure (BP) levels according to the European Society of Cardiology / European School of Haematology (ESC/ESH) Guidelines, after treatment with eprosartan for 6 months under standard medical practice conditions. The absolute change in Systolic blood pressure from baseline will also be calculated.

This study also aims in the evaluation of Framingham stroke risk profile score of patients treated with eprosartan under standard clinical practice conditions during the observation period. Besides the primary and the secondary objective of the study, the assessment of the percentage of patients who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) (overall and per observed event) and the percentage of patients who discontinued treatment prematurely before the advent of the 6-month observation period due to toxicity to the study medication constitutes another important objective that is related to the safety of the treatment.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Stroke

Detailed Description

This is an open, non-interventional, non-comparative study. Therefore, there is no control group, randomization, or blinding involved. The target subject population is hypertensive patients who are being treated with eprosartan under standard clinical conditions and the locally approved Summary of Product Characteristics (SmPCs). Treatment selection is independent of the study conduct according to the local requirements of the Health Authorities for the definition of non-interventional studies being conducted in Greece. Therefore, the inclusion/exclusion criteria of this study follow the clinical decision of the participating physician, when prescribing the study medication(s) under standard clinical practice. The study plans to enroll 600 patients from 100 participating centers (hospitals and private physicians). This number includes an additional 25% cushion compared to the required sample size to ensure that sufficient data is collected for the subsequent statistical analysis. The study has been designed to be non-interventional and subsequently follows the per center standard practice of treatment, medical care and visits. As a result a rigid visit schedule could not be imposed. However, when taking into account the overall local standard practice, an overview of the visit schedule is indicated per subject:

• A baseline visit at the beginning of the 6-month observation period where the investigator will check the eligibility of the subject and will record the baseline data provided that the subject is eligible and has given the signed and dated informed consent.

• A final visit at the end of the 6-month treatment period (also observation period), and

• At least one interim visit (according to the standard clinical practice, within baseline and final visit)

Study Design

• Study Type: Observational
• Actual Enrollment: 533 participants
• Time Perspective: Prospective
• Official Title: Stroke Estimation (According to Framingham Profile ParameterS) in Patients Under medicAtion Due to Essential Hypertension. (NASA)
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Hypertensive patients All eligible hypertensive patients treated with eprosartan

Outcome Measures

Primary Outcome Measures

1. 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. [Baseline up to 6 months]

   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)]

2. The Absolute Change in Systolic Blood Pressure From Baseline [Baseline up to 6 months]

   The absolute change in systolic Blood Pressure from baseline

Secondary Outcome Measures

1. Change in Framingham Stroke Risk Profile Scores of the Participating Patients [Baseline up to 6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult patients (age greater or equal to 18 years)

2. Hypertensive patients, with a sitting Systolic Blood Pressure above 140 mmHg or 130 mmHg in diabetics and high/very high risk patients, according to ESC/ESH Guidelines

3. Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice

4. Patients with at least one of the following conditions:

• Newly diagnosed hypertension,

• Inability to tolerate other antihypertensive medications, or

• Lack of response to current antihypertensive medication(s)

Exclusion Criteria:

1. Any contraindication to eprosartan or the excipients (according to the local label)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 62499	Agrinio		Greece	30100
2	Site Reference ID/Investigator# 62500	Agrinio		Greece	30100
3	Site Reference ID/Investigator# 62577	Alimos		Greece	17456
4	Site Reference ID/Investigator# 62386	Athens		Greece	10552
5	Site Reference ID/Investigator# 62398	Athens		Greece	11143
6	Site Reference ID/Investigator# 62389	Athens		Greece	11251
7	Site Reference ID/Investigator# 62384	Athens		Greece	11521
8	Site Reference ID/Investigator# 62392	Chalandri		Greece	15234
9	Site Reference ID/Investigator# 62395	Chalandri		Greece	15234
10	Site Reference ID/Investigator# 62391	Chalandri		Greece	34100
11	Site Reference ID/Investigator# 62633	Chalkida		Greece	15236
12	Site Reference ID/Investigator# 62629	Chalkida		Greece	34100
13	Site Reference ID/Investigator# 62507	Chania		Greece	73132
14	Site Reference ID/Investigator# 62508	Chania		Greece	73132
15	Site Reference ID/Investigator# 62511	Chania		Greece	73132
16	Site Reference ID/Investigator# 62588	Chania		Greece	73134
17	Site Reference ID/Investigator# 62484	Drama		Greece	66100
18	Site Reference ID/Investigator# 62518	Eleftherio, Thessaloniki		Greece	56334
19	Site Reference ID/Investigator# 62512	Euosmos, Thessaloniki		Greece	56224
20	Site Reference ID/Investigator# 62390	Galatsi		Greece	11147
21	Site Reference ID/Investigator# 62584	Glyfada		Greece	16561
22	Site Reference ID/Investigator# 62586	Glyfada		Greece	16561
23	Site Reference ID/Investigator# 62589	Heraklion		Greece	18536
24	Site Reference ID/Investigator# 62591	Heraklion		Greece	71305
25	Site Reference ID/Investigator# 62505	Heraklion		Greece	71307
26	Site Reference ID/Investigator# 62593	Heraklion		Greece	71307
27	Site Reference ID/Investigator# 62587	Heraklion		Greece	71409
28	Site Reference ID/Investigator# 62503	Ioannina		Greece	45221
29	Site Reference ID/Investigator# 62497	Ioannina		Greece	45332
30	Site Reference ID/Investigator# 62493	Ioannina		Greece	45444
31	Site Reference ID/Investigator# 62487	Kalamata		Greece	24100
32	Site Reference ID/Investigator# 62580	Kallithea		Greece	17672
33	Site Reference ID/Investigator# 62645	Kavala		Greece	65302
34	Site Reference ID/Investigator# 62644	Kavala		Greece	65403
35	Site Reference ID/Investigator# 62483	Komotini		Greece	67100
36	Site Reference ID/Investigator# 62642	Komotini		Greece	69100
37	Site Reference ID/Investigator# 62575	Korydallos		Greece	18120
38	Site Reference ID/Investigator# 62631	Lamia		Greece	35100
39	Site Reference ID/Investigator# 62635	Lamia		Greece	35100
40	Site Reference ID/Investigator# 62626	Larisa		Greece	41221
41	Site Reference ID/Investigator# 62638	Larisa		Greece	41221
42	Site Reference ID/Investigator# 62628	Larisa		Greece	41222
43	Site Reference ID/Investigator# 62637	Larisa		Greece	41223
44	Site Reference ID/Investigator# 62574	Megara		Greece	19100
45	Site Reference ID/Investigator# 62630	N. Ionia Volou		Greece	38446
46	Site Reference ID/Investigator# 62397	Nea Erythraia		Greece	14671
47	Site Reference ID/Investigator# 62385	Nea Filadelfeia		Greece	14671
48	Site Reference ID/Investigator# 62399	Nea Smyrni		Greece	17121
49	Site Reference ID/Investigator# 62582	Nikaia		Greece	18450
50	Site Reference ID/Investigator# 62585	P. Faliro		Greece	17564
51	Site Reference ID/Investigator# 62393	Paiania		Greece	19002
52	Site Reference ID/Investigator# 62394	Pallini		Greece	15351
53	Site Reference ID/Investigator# 62522	Panorama		Greece	55236
54	Site Reference ID/Investigator# 62501	Patras		Greece	26221
55	Site Reference ID/Investigator# 62502	Patras		Greece	26221
56	Site Reference ID/Investigator# 62492	Patras		Greece	26442
57	Site Reference ID/Investigator# 62579	Peiraias		Greece	18536
58	Site Reference ID/Investigator# 62401	Peristeri		Greece	12132
59	Site Reference ID/Investigator# 62402	Peristeri		Greece	12136
60	Site Reference ID/Investigator# 62578	Peristeri		Greece	12136
61	Site Reference ID/Investigator# 62388	Peuki		Greece	15121
62	Site Reference ID/Investigator# 62396	Peuki		Greece	15121
63	Site Reference ID/Investigator# 62520	Polykastro		Greece	61200
64	Site Reference ID/Investigator# 62495	Pyrgos		Greece	27100
65	Site Reference ID/Investigator# 62496	Pyrgos		Greece	27100
66	Site Reference ID/Investigator# 62510	Rodes		Greece	85100
67	Site Reference ID/Investigator# 62590	Rodes		Greece	85100
68	Site Reference ID/Investigator# 62592	Rodes		Greece	85100
69	Site Reference ID/Investigator# 62640	Sappes Komotinis		Greece	69100
70	Site Reference ID/Investigator# 62641	Serres		Greece	62122
71	Site Reference ID/Investigator# 62513	Sykies		Greece	56626
72	Site Reference ID/Investigator# 62509	Thermi, Thessaloniki		Greece	57001
73	Site Reference ID/Investigator# 62514	Thessaloniki		Greece	54022
74	Site Reference ID/Investigator# 62517	Thessaloniki		Greece	54623
75	Site Reference ID/Investigator# 62516	Thessaloniki		Greece	55132
76	Site Reference ID/Investigator# 62521	Thessaloniki		Greece	63077
77	Site Reference ID/Investigator# 62523	Thessaloniki		Greece	63200
78	Site Reference ID/Investigator# 62506	Veria		Greece	59100
79	Site Reference ID/Investigator# 62627	Volos		Greece	38221
80	Site Reference ID/Investigator# 62634	Volos		Greece	38221
81	Site Reference ID/Investigator# 62486	Vraxnaiika		Greece	25002
82	Site Reference ID/Investigator# 62387	Vyronas		Greece	16233
83	Site Reference ID/Investigator# 62485	Xanthi		Greece	67100
84	Site Reference ID/Investigator# 62488	Xanthi		Greece	69300

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Maria Daskalaki, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01562613
• Other Study ID Numbers: P13-165
• First Posted: Mar 26, 2012
• Last Update Posted: Aug 12, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Abbott: Stroke; Hypertension
• Additional relevant MeSH terms: Stroke; Hypertension

Study Results

Participant Flow

Arm/Group Title	Hypertensive Patients
Arm/Group Description	All eligible hypertensive patients treated with eprosartan
Period Title: Overall Study
STARTED	533
COMPLETED	529
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Hypertensive Patients
Arm/Group Description	All eligible hypertensive patients treated with eprosartan
Overall Participants	533
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.4 (11.9)
Sex: Female, Male (Count of Participants)
Female	276 51.8%
Male	257 48.2%
Region of Enrollment (participants) [Number]
Greece	533 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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)]
Time Frame	Baseline up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hypertensive Patients
Arm/Group Description	All eligible hypertensive patients treated with eprosartan
Measure Participants	529
Number (95% Confidence Interval) [Percentage of participants]	62.8 11.8%

2. Primary Outcome

Title	The Absolute Change in Systolic Blood Pressure From Baseline
Description	The absolute change in systolic Blood Pressure from baseline
Time Frame	Baseline up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hypertensive Patients
Arm/Group Description	All eligible hypertensive patients treated with eprosartan
Measure Participants	529
Mean (Standard Deviation) [mmHg]	-31.1 (11.9)

3. Secondary Outcome

Title	Change in Framingham Stroke Risk Profile Scores of the Participating Patients
Description	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.
Time Frame	Baseline up to 6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Hypertensive Patients
Arm/Group Description	All eligible hypertensive patients treated with eprosartan
Measure Participants	370
Baseline	14 (1.7)
6 months	11

Adverse Events

Arm/Group Title	Hypertensive Patients
Arm/Group Description	All eligible hypertensive patients treated with eprosartan
All Cause Mortality
	Hypertensive Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Hypertensive Patients
	Affected / at Risk (%)	# Events
Total	0/533 (0%)
Other (Not Including Serious) Adverse Events
	Hypertensive Patients
	Affected / at Risk (%)	# Events
Total	7/533 (1.3%)
Cardiac disorders
Dizziness	1/533 (0.2%)	1
Bradycardia	1/533 (0.2%)	1
Gastrointestinal disorders
Gastritis	1/533 (0.2%)	1
Gastrooesophageal reflux disease	1/533 (0.2%)	1
Infections and infestations
Gastroenteritis	1/533 (0.2%)	1
Respiratory tract infection	1/533 (0.2%)	1
Urinary tract infection	1/533 (0.2%)	1
Reproductive system and breast disorders
Prostatitis	1/533 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/533 (0.2%)	1
Vascular disorders
Hypotension	1/533 (0.2%)	1

Limitations/Caveats

No important limitations apply. Missing data and drop-out rate was very low; but some factors required for patient CV (cardiovascular) risk classification were unknown and may have resulted in CV risk underestimation in a limited number of patients.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.