Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients
Treatment Adherence to JNC 7(Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, 7th Report) Guidelines in Cardiovascular (CV)-Risk Patients Across the Middle East - the Impact of Ramadan Fasting on Achieving Treatment Goals in Daily Practice
1 other identifier
observational
1,674
5 countries
132
Brief Summary
This is an out-patient based prospective, multi-centre, observational post-marketing surveillance study amongst internists and cardiologists. In this study, patients with essential hypertension and at least one additional risk factor will be included. Patients may take any antihypertensive treatment which is approved for cardiovascular protection including Micardis 80 mg / Micardis Plus. Patients will be followed over one year in four visits from baseline to endpoint with an additional visit before and after the month of Ramadan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
Typical duration for all trials
132 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
August 10, 2015
CompletedAugust 10, 2015
July 1, 2015
2.8 years
May 13, 2013
July 15, 2015
July 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52
The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) \<140/90 mmHg) in a primary-care setting at week 52. This variable was derived from the mean sitting blood pressure assessed by the investigators at week 52. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.
Up to 52 weeks
Secondary Outcomes (12)
Achieving JNC 7 Treatment Goals After Ramadan
1 month
Cardiovascular Events
Up to 52 weeks
The Overall Assessment of Treatment by Patients at 52 Weeks
Up to 52 weeks
The Overall Assessment of Treatment by Physicians at 52 Weeks
Up to 52 weeks
Compliance of Patients up to 10 Days Before Ramadan
10 days before Ramadan
- +7 more secondary outcomes
Eligibility Criteria
Hypertensive patients wih at least one CV risk factor
You may qualify if:
- Male or female of age 18 years or older;
- Newly diagnosed and untreated or previously treated and uncontrolled patients with essential hypertension;
- Seated blood pressure of \>140/90 mmHg or \>130/80 mmHg in patients with diabetes mellitus or chronic kidney disease;
- Patients with at least one cardiovascular (cv) risk factor;
- Ability to provide written informed consent.
You may not qualify if:
- Patients with contraindications to the prescribed antihypertensive medications;
- Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception;
- Patients who are participating in any other study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (132)
Boehringer Ingelheim Investigational Site 106
Algiers, Algeria
Boehringer Ingelheim Investigational Site 107
Algiers, Algeria
Boehringer Ingelheim Investigational Site 108
Algiers, Algeria
Boehringer Ingelheim Investigational Site 109
Algiers, Algeria
Boehringer Ingelheim Investigational Site 110
Algiers, Algeria
Boehringer Ingelheim Investigational Site 111
Algiers, Algeria
Boehringer Ingelheim Investigational Site 112
Algiers, Algeria
Boehringer Ingelheim Investigational Site 113
Algiers, Algeria
Boehringer Ingelheim Investigational Site 114
Algiers, Algeria
Boehringer Ingelheim Investigational Site 115
Algiers, Algeria
Boehringer Ingelheim Investigational Site 116
Algiers, Algeria
Boehringer Ingelheim Investigational Site 117
Algiers, Algeria
Boehringer Ingelheim Investigational Site 118
Algiers, Algeria
Boehringer Ingelheim Investigational Site 119
Algiers, Algeria
Boehringer Ingelheim Investigational Site 120
Algiers, Algeria
Boehringer Ingelheim Investigational Site 121
Algiers, Algeria
Boehringer Ingelheim Investigational Site 122
Algiers, Algeria
Boehringer Ingelheim Investigational Site 123
Algiers, Algeria
Boehringer Ingelheim Investigational Site 124
Algiers, Algeria
Boehringer Ingelheim Investigational Site 125
Algiers, Algeria
Boehringer Ingelheim Investigational Site 126
Algiers, Algeria
Boehringer Ingelheim Investigational Site 127
Algiers, Algeria
Boehringer Ingelheim Investigational Site 128
Algiers, Algeria
Boehringer Ingelheim Investigational Site 129
Algiers, Algeria
Boehringer Ingelheim Investigational Site 130
Algiers, Algeria
Boehringer Ingelheim Investigational Site 131
Algiers, Algeria
Boehringer Ingelheim Investigational Site 29
Al Fayyum, Egypt
Boehringer Ingelheim Investigational Site 15
Alexandria, Egypt
Boehringer Ingelheim Investigational Site 19
Alexandria, Egypt
Boehringer Ingelheim Investigational Site 21
Alexandria, Egypt
Boehringer Ingelheim Investigational Site 22
Alexandria, Egypt
Boehringer Ingelheim Investigational Site 23
Alexandria, Egypt
Boehringer Ingelheim Investigational Site 3
Alexandria, Egypt
Boehringer Ingelheim Investigational Site 6
Alexandria, Egypt
Boehringer Ingelheim Investigational Site 18
Asyut, Egypt
Boehringer Ingelheim Investigational Site 27
Asyut, Egypt
Boehringer Ingelheim Investigational Site 11
Banisuif, Egypt
Boehringer Ingelheim Investigational Site 10
Cairo, Egypt
Boehringer Ingelheim Investigational Site 12
Cairo, Egypt
Boehringer Ingelheim Investigational Site 13
Cairo, Egypt
Boehringer Ingelheim Investigational Site 14
Cairo, Egypt
Boehringer Ingelheim Investigational Site 17
Cairo, Egypt
Boehringer Ingelheim Investigational Site 1
Cairo, Egypt
Boehringer Ingelheim Investigational Site 20
Cairo, Egypt
Boehringer Ingelheim Investigational Site 24
Cairo, Egypt
Boehringer Ingelheim Investigational Site 25
Cairo, Egypt
Boehringer Ingelheim Investigational Site 26
Cairo, Egypt
Boehringer Ingelheim Investigational Site 28
Cairo, Egypt
Boehringer Ingelheim Investigational Site 2
Cairo, Egypt
Boehringer Ingelheim Investigational Site 4
Cairo, Egypt
Boehringer Ingelheim Investigational Site 5
Cairo, Egypt
Boehringer Ingelheim Investigational Site 7
Cairo, Egypt
Boehringer Ingelheim Investigational Site 8
Cairo, Egypt
Boehringer Ingelheim Investigational Site 9
Cairo, Egypt
Boehringer Ingelheim Investigational Site 30
Domiat, Egypt
Boehringer Ingelheim Investigational Site 16
Menia, Egypt
Boehringer Ingelheim Investigational Site 31
Tanta, Egypt
Boehringer Ingelheim Investigational Site 66
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 67
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 68
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 69
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 70
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 71
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 72
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 73
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 74
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 75
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 76
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 77
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 78
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 79
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 80
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 81
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 82
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 83
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 84
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 85
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 86
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 87
Beirut, Lebanon
Boehringer Ingelheim Investigational Site 88
Tripoli, Lebanon
Boehringer Ingelheim Investigational Site 89
Tripoli, Lebanon
Boehringer Ingelheim Investigational Site 90
Tripoli, Lebanon
Boehringer Ingelheim Investigational Site 91
Tripoli, Lebanon
Boehringer Ingelheim Investigational Site 92
Tripoli, Lebanon
Boehringer Ingelheim Investigational Site 93
Tripoli, Lebanon
Boehringer Ingelheim Investigational Site 94
Tripoli, Lebanon
Boehringer Ingelheim Investigational Site 35
Dammam, Saudi Arabia
Boehringer Ingelheim Investigational Site 36
Dammam, Saudi Arabia
Boehringer Ingelheim Investigational Site 37
Dammam, Saudi Arabia
Boehringer Ingelheim Investigational Site 38
Hofuf, Saudi Arabia
Boehringer Ingelheim Investigational Site 50
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 51
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 52
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 53
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 54
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 55
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 56
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 57
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 58
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 59
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 60
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 61
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 62
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 63
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 64
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 65
Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 32
Khobar, Saudi Arabia
Boehringer Ingelheim Investigational Site 33
Khobar, Saudi Arabia
Boehringer Ingelheim Investigational Site 34
Khobar, Saudi Arabia
Boehringer Ingelheim Investigational Site 105
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 39
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 40
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 41
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 42
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 43
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 44
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 45
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 46
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 47
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 48
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 49
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 100
Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 101
Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 102
Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 103
Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 104
Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 132
Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 95
Sharjah city, United Arab Emirates
Boehringer Ingelheim Investigational Site 96
Sharjah city, United Arab Emirates
Boehringer Ingelheim Investigational Site 97
Sharjah city, United Arab Emirates
Boehringer Ingelheim Investigational Site 98
Sharjah city, United Arab Emirates
Boehringer Ingelheim Investigational Site 99
Sharjah city, United Arab Emirates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 15, 2013
Study Start
October 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
August 10, 2015
Results First Posted
August 10, 2015
Record last verified: 2015-07