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

May 13, 2013
August 13, 2014
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 (V4). [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01853839 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ] [ Designated as safety issue: No ]
  • The percentage of patients achieving JNC 7 treatment goals after Ramadan (V3) in fasting and non-fasting patients [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The overall assessment of treatment by patients and physicians at 52 weeks [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • The frequency and type of adverse events evaluation of ARBs when given in combination with CCBs [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
  • The difference in CV events between different medications used in the study [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
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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.
Both
18 Years and older
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
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP