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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:
ClinicalTrials.gov Identifier:
NCT01853839
First Posted: May 15, 2013
Last Update Posted: August 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
May 13, 2013
May 15, 2013
July 15, 2015
August 10, 2015
August 10, 2015
October 2011
July 2014   (Final data collection date for primary outcome measure)
Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52 [ Time Frame: 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.
The primary objective is to assess the proportion of hypertensive patients with at least one CV risk factor enrolled in the study who achieve the JNC 7 treatment goals (BP <140/90 mmHg) in a primary-care setting at week 52 (V4). [ Time Frame: Up to 52 weeks ]
Complete list of historical versions of study NCT01853839 on ClinicalTrials.gov Archive Site
  • Achieving JNC 7 Treatment Goals After Ramadan [ Time Frame: 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.
  • Cardiovascular Events [ Time Frame: Up to 52 weeks ]
    Percentage of participants who experienced a major cardiovascular (CV) event
  • The Overall Assessment of Treatment by Patients at 52 Weeks [ Time Frame: 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.
  • The Overall Assessment of Treatment by Physicians at 52 Weeks [ Time Frame: 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.
  • Compliance of Patients up to 10 Days Before Ramadan [ Time Frame: 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 [ Time Frame: 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".
  • Compliance of Patients During the Whole Study Duration (52 Weeks) [ Time Frame: 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".
  • 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 ]
    Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)
  • The Difference in Systolic Blood Pressure Before and After the Month of Ramadan [ Time Frame: 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 Difference in Diastolic Blood Pressure Before and After the Month of Ramadan [ Time Frame: 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
  • The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration [ Time Frame: 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.
  • Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs) [ Time Frame: 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 percentage of patients achieving JNC 7 treatment goals (BP <130/80 mmHg in patients with diabetes or chronic kidney disease or BP <140/90 mmHg in all other patients) after 1 year of treatment [ Time Frame: up to 52 weeks ]
  • The percentage of patients achieving JNC 7 treatment goals after Ramadan (V3) in fasting and non-fasting patients [ Time Frame: up to 52 weeks ]
  • The difference in systolic and diastolic blood pressure before and after the month of Ramadan in individual patients and cohorts [ Time Frame: up to 52 weeks ]
  • The compliance and percentage of patients achieving JNC 7 treatment when treated by internists and cardiologists as primary physician [ Time Frame: Up to 52 weeks ]
  • The overall assessment of treatment by patients and physicians at 52 weeks [ Time Frame: Up to 52 weeks ]
  • The frequency and type of adverse events evaluation of ARBs when given in combination with CCBs [ Time Frame: Up to 52 weeks ]
  • The difference in CV events between different medications used in the study [ Time Frame: Up to 52 weeks ]
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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
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.
Purpose:
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Hypertensive patients wih at least one CV risk factor
Hypertension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1674
July 2014
July 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Egypt,   Lebanon,   Saudi Arabia,   United Arab Emirates
 
 
NCT01853839
502.602
Not Provided
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Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2015
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