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Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01853839
First received: May 13, 2013
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Achievement of the JNC 7 treatment goals (BP <140/90 mmHg) at week 52 (V4). [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achieving JNC 7 treatment goals after Ramadan (V3) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • CV events [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
  • The overall assessment of treatment by patients at 52 weeks [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • The overall assessment of treatment by physicians at 52 weeks [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Compliance of patients during the whole study duration (treated by internists and cardiologists as primary physician) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Achievement of the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • The difference in systolic blood pressure before and after the month of Ramadan [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • The difference in diastolic blood pressure before and after the month of Ramadan [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • The percentage of patients achieving JNC 7 treatment goals at the end of the 1 year treatment duration [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Adverse events under Angiotensin II (Type 1) Receptor Blockers (ARBs) treatment when given in combination with Calcium-Channel Blockers (CCBs) during the whole study duration [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1674
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Purpose:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hypertensive patients wih at least one CV risk factor

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01853839

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Locations
Algeria
Boehringer Ingelheim Investigational Site 121
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 106
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
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
Assuit, Egypt
Boehringer Ingelheim Investigational Site 27
Assuit, Egypt
Boehringer Ingelheim Investigational Site 11
Banisuif, Egypt
Boehringer Ingelheim Investigational Site 14
Cairo, 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 9
Cairo, Egypt
Boehringer Ingelheim Investigational Site 17
Cairo, Egypt
Boehringer Ingelheim Investigational Site 2
Cairo, Egypt
Boehringer Ingelheim Investigational Site 20
Cairo, Egypt
Boehringer Ingelheim Investigational Site 1
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 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 24
Cairo, Egypt
Boehringer Ingelheim Investigational Site 30
Domiat, Egypt
Boehringer Ingelheim Investigational Site 29
Fayoum, Egypt
Boehringer Ingelheim Investigational Site 16
Menia, Egypt
Boehringer Ingelheim Investigational Site 31
Tanta, Egypt
Lebanon
Boehringer Ingelheim Investigational Site 84
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 66
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
Saudi Arabia
Boehringer Ingelheim Investigational Site 32
Alkhobar, Saudi Arabia
Boehringer Ingelheim Investigational Site 33
Alkhobar, Saudi Arabia
Boehringer Ingelheim Investigational Site 34
Alkhobar, Saudi Arabia
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 41
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 39
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 40
Riyadh, Saudi Arabia
Boehringer Ingelheim Investigational Site 105
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
United Arab Emirates
Boehringer Ingelheim Investigational Site 132
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 100
Dubai, 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 97
Sharjah, United Arab Emirates
Boehringer Ingelheim Investigational Site 98
Sharjah, United Arab Emirates
Boehringer Ingelheim Investigational Site 99
Sharjah, United Arab Emirates
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01853839     History of Changes
Other Study ID Numbers: 502.602
Study First Received: May 13, 2013
Last Updated: August 13, 2014
Health Authority: Algeria: Ministry of Health
Egypt: Ministry of Health and Population
Lebanon: Ministry of Public Health
Saudi Arabia: Ministry of Health
United Arab Emirates: Drug Cont Dept-Med&Pharm Cont-Ministry of Health

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014