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

  Show 132 Study Locations
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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014