Clinical trial NCT01853839: Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 1674
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients wih at least one CV risk factor

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.

Detailed description: Purpose:

Eligibility criteria: Inclusion criteria:

1. Male or female of age 18 years or older;
2. Newly diagnosed and untreated or previously treated and uncontrolled patients with essential hypertension;
3. Seated blood pressure of \>140/90 mmHg or \>130/80 mmHg in patients with diabetes mellitus or chronic kidney disease;
4. Patients with at least one cardiovascular (cv) risk factor;
5. Ability to provide written informed consent.

Exclusion criteria:

1. Patients with contraindications to the prescribed antihypertensive medications;
2. Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception;
3. Patients who are participating in any other study protocol.

Primary outcomes:
measure: Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Achieving JNC 7 Treatment Goals After Ramadan
timeFrame: 1 month
measure: Cardiovascular Events
timeFrame: Up to 52 weeks
measure: The Overall Assessment of Treatment by Patients at 52 Weeks
timeFrame: Up to 52 weeks
measure: The Overall Assessment of Treatment by Physicians at 52 Weeks
timeFrame: Up to 52 weeks
measure: Compliance of Patients up to 10 Days Before Ramadan
timeFrame: 10 days before Ramadan
measure: Compliance of Patients up to 10 Days After Ramadan
timeFrame: 10 days after Ramadan
measure: Compliance of Patients During the Whole Study Duration (52 Weeks)
timeFrame: Up to 52 weeks
measure: Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician)
timeFrame: Up to 52 weeks
measure: The Difference in Systolic Blood Pressure Before and After the Month of Ramadan
timeFrame: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks
measure: The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan
timeFrame: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks
measure: The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration
timeFrame: Up to 52 weeks
measure: Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs)
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 106
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 107
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 108
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 109
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 110
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 111
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 112
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 113
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 114
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 115
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 116
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 117
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 118
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 119
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 120
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 121
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 122
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 123
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 124
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 125
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 126
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 127
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 128
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 129
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 130
city: Algiers
country: Algeria
facility: Boehringer Ingelheim Investigational Site 131
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 15
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 19
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 21
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 22
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 23
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 3
city: Alexandria
country: Egypt
facility: Boehringer Ingelheim Investigational Site 6
city: Assuit
country: Egypt
facility: Boehringer Ingelheim Investigational Site 18
city: Assuit
country: Egypt
facility: Boehringer Ingelheim Investigational Site 27
city: Banisuif
country: Egypt
facility: Boehringer Ingelheim Investigational Site 11
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 10
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 12
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 13
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 14
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 17
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 1
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 20
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 24
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 25
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 26
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 28
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 2
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 4
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 5
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 7
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 8
city: Cairo
country: Egypt
facility: Boehringer Ingelheim Investigational Site 9
city: Domiat
country: Egypt
facility: Boehringer Ingelheim Investigational Site 30
city: Fayoum
country: Egypt
facility: Boehringer Ingelheim Investigational Site 29
city: Menia
country: Egypt
facility: Boehringer Ingelheim Investigational Site 16
city: Tanta
country: Egypt
facility: Boehringer Ingelheim Investigational Site 31
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 66
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 67
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 68
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 69
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 70
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 71
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 72
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 73
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 74
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 75
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 76
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 77
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 78
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 79
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 80
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 81
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 82
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 83
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 84
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 85
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 86
city: Beirut
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 87
city: Tripoli
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 88
city: Tripoli
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 89
city: Tripoli
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 90
city: Tripoli
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 91
city: Tripoli
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 92
city: Tripoli
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 93
city: Tripoli
country: Lebanon
facility: Boehringer Ingelheim Investigational Site 94
city: Alkhobar
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 32
city: Alkhobar
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 33
city: Alkhobar
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 34
city: Dammam
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 35
city: Dammam
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 36
city: Dammam
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 37
city: Hofuf
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 38
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 50
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 51
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 52
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 53
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 54
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 55
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 56
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 57
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 58
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 59
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 60
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 61
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 62
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 63
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 64
city: Jeddah
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 65
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 105
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 39
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 40
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 41
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 42
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 43
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 44
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 45
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 46
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 47
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 48
city: Riyadh
country: Saudi Arabia
facility: Boehringer Ingelheim Investigational Site 49
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 100
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 101
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 102
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 103
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 104
city: Dubai
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 132
city: Sharjah
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 95
city: Sharjah
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 96
city: Sharjah
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 97
city: Sharjah
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 98
city: Sharjah
country: United Arab Emirates
facility: Boehringer Ingelheim Investigational Site 99
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: