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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853839
• Other study ID #: 502.602
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: July 15, 2015
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Algeria: Ministry of HealthEgypt: Ministry of Health and PopulationLebanon: Ministry of Public HealthSaudi Arabia: Ministry of HealthUnited Arab Emirates: Drug Cont Dept-Med&Pharm Cont-Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

Purpose:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1674
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Algeria	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
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 1	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 14	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 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 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 29	Fayoum
Egypt	Boehringer Ingelheim Investigational Site 16	Menia
Egypt	Boehringer Ingelheim Investigational Site 31	Tanta
Lebanon	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
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 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
United Arab Emirates	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
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Algeria,  Egypt,  Lebanon,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Achieving JNC 7 Treatment Goals After Ramadan	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.	1 month	No
Secondary	Cardiovascular Events	Percentage of participants who experienced a major cardiovascular (CV) event	Up to 52 weeks	Yes
Secondary	The Overall Assessment of Treatment by Patients at 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.	Up to 52 weeks	No
Secondary	The Overall Assessment of Treatment by Physicians at 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.	Up to 52 weeks	No
Secondary	Compliance of Patients up to 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".	10 days before Ramadan	No
Secondary	Compliance of Patients up to 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".	10 days after Ramadan	No
Secondary	Compliance of Patients During the Whole Study Duration (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".	Up to 52 weeks	No
Secondary	Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician)	Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)	Up to 52 weeks	No
Secondary	The Difference in Systolic Blood Pressure Before and After the Month of Ramadan	Change from baseline in systolic blood pressure before and after the month of Ramadan	Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks	No
Secondary	The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan	Change from baseline in diastolic blood pressure before and after the month of Ramadan	Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks	No
Secondary	The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration	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.	Up to 52 weeks	No
Secondary	Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs)	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.	Up to 52 weeks	Yes

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