Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients
- Conditions
- Hypertension
- Registration Number
- NCT01853839
- Lead Sponsor
- Boehringer Ingelheim
- 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:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1674
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52 Up to 52 weeks 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.
- Secondary Outcome Measures
Name Time Method Achieving JNC 7 Treatment Goals After Ramadan 1 month 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 after Ramadan. This variable was derived from the mean sitting blood pressure assessed by the investigators after Ramadan. 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.
Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician) Up to 52 weeks Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)
The Overall Assessment of Treatment by Patients at 52 Weeks Up to 52 weeks The overall assessment of treatment by patients at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.
Compliance of Patients During the Whole Study Duration (52 Weeks) Up to 52 weeks Compliance of patients during the whole study duration (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from "none of the time" to "all of the time".
The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks Change from baseline in diastolic blood pressure before and after the month of Ramadan
Cardiovascular Events Up to 52 weeks Percentage of participants who experienced a major cardiovascular (CV) event
Compliance of Patients up to 10 Days Before Ramadan 10 days before Ramadan Compliance of patients up to 10 days before ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from "none of the time" to "all of the time".
Compliance of Patients up to 10 Days After Ramadan 10 days after Ramadan Compliance of patients up to 10 days after Ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from "none of the time" to "all of the time".
Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs) Up to 52 weeks Number of participants with adverse events in participants receiving Angiotensin II (Type 1) Receptor Blockers (ARBs) when given in combination with Calcium-Channel Blockers (CCBs) during the whole study duration.
The Overall Assessment of Treatment by Physicians at 52 Weeks Up to 52 weeks The overall assessment of treatment by physicians at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.
The Difference in Systolic Blood Pressure Before and After the Month of Ramadan Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks Change from baseline in systolic blood pressure before and after the month of Ramadan
The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration Up to 52 weeks 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 the end of the 1 year treatment duration. This variable was derived from the mean sitting blood pressure assessed by the investigators at the end of the 1 year treatment duration. 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. At this timepoint, a diagnosis of diabetes mellitus and/or kidney disease was also taken into account. Subjects with either of the mentioned conditions had to have systolic blood pressure lower than 130 mm Hg and diastolic blood pressure below 80 mm Hg to satisfy JNC 7 treatment goals.
Trial Locations
- Locations (132)
Boehringer Ingelheim Investigational Site 109
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 110
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 123
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 124
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 106
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 108
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 114
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 107
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 111
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 112
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 120
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 113
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 118
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 121
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 129
🇩🇿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 119
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 122
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 125
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 126
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 131
🇩🇿Algiers, Algeria
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 51
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 52
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 59
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 62
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 64
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 65
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 44
🇸🇦Riyadh, 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 46
🇸🇦Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 102
🇦🇪Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 47
🇸🇦Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 48
🇸🇦Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 103
🇦🇪Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 101
🇦🇪Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 132
🇦🇪Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 104
🇦🇪Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 97
🇦🇪Sharjah, United Arab Emirates
Boehringer Ingelheim Investigational Site 95
🇦🇪Sharjah, United Arab Emirates
Boehringer Ingelheim Investigational Site 96
🇦🇪Sharjah, United Arab Emirates
Boehringer Ingelheim Investigational Site 98
🇦🇪Sharjah, United Arab Emirates
Boehringer Ingelheim Investigational Site 22
🇪🇬Alexandria, Egypt
Boehringer Ingelheim Investigational Site 6
🇪🇬Alexandria, Egypt
Boehringer Ingelheim Investigational Site 27
🇪🇬Assuit, Egypt
Boehringer Ingelheim Investigational Site 1
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 15
🇪🇬Alexandria, Egypt
Boehringer Ingelheim Investigational Site 11
🇪🇬Banisuif, Egypt
Boehringer Ingelheim Investigational Site 13
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 3
🇪🇬Alexandria, Egypt
Boehringer Ingelheim Investigational Site 10
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 19
🇪🇬Alexandria, Egypt
Boehringer Ingelheim Investigational Site 21
🇪🇬Alexandria, Egypt
Boehringer Ingelheim Investigational Site 23
🇪🇬Alexandria, Egypt
Boehringer Ingelheim Investigational Site 17
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 24
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 68
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 71
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 73
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 12
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 20
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 25
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 35
🇸🇦Dammam, Saudi Arabia
Boehringer Ingelheim Investigational Site 80
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 14
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 5
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 7
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 9
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 69
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 54
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 2
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 31
🇪🇬Tanta, Egypt
Boehringer Ingelheim Investigational Site 70
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 72
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 83
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 85
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 8
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 86
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 67
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 33
🇸🇦Alkhobar, Saudi Arabia
Boehringer Ingelheim Investigational Site 34
🇸🇦Alkhobar, Saudi Arabia
Boehringer Ingelheim Investigational Site 29
🇪🇬Fayoum, Egypt
Boehringer Ingelheim Investigational Site 66
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 77
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 78
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 81
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 32
🇸🇦Alkhobar, Saudi Arabia
Boehringer Ingelheim Investigational Site 16
🇪🇬Menia, Egypt
Boehringer Ingelheim Investigational Site 87
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 89
🇱🇧Tripoli, Lebanon
Boehringer Ingelheim Investigational Site 74
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 79
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 82
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 84
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 88
🇱🇧Tripoli, Lebanon
Boehringer Ingelheim Investigational Site 99
🇦🇪Sharjah, United Arab Emirates
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 41
🇸🇦Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 42
🇸🇦Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 43
🇸🇦Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 45
🇸🇦Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 49
🇸🇦Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 100
🇦🇪Dubai, United Arab Emirates
Boehringer Ingelheim Investigational Site 127
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 128
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 130
🇩🇿Algiers, Algeria
Boehringer Ingelheim Investigational Site 18
🇪🇬Assuit, Egypt
Boehringer Ingelheim Investigational Site 4
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 30
🇪🇬Domiat, Egypt
Boehringer Ingelheim Investigational Site 75
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 76
🇱🇧Beirut, Lebanon
Boehringer Ingelheim Investigational Site 50
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 53
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 57
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 55
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 56
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 58
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 60
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 61
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 63
🇸🇦Jeddah, Saudi Arabia
Boehringer Ingelheim Investigational Site 26
🇪🇬Cairo, Egypt
Boehringer Ingelheim Investigational Site 28
🇪🇬Cairo, Egypt