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: July 15, 2015
Last verified: July 2015
Results First Received: July 15, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hypertension

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients are included a non-completers if they did not meet the definition of the intention-to-treat (ITT) population (all patients, who received at least one dose of study medication) or if the subject attended the week 52 visit less than 26 weeks after baseline.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Subjects

Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.

All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks.


Participant Flow:   Overall Study
    All Subjects  
STARTED     2092  
COMPLETED     1663  
NOT COMPLETED     429  
Violated inclusion criteria                 2  
Not meet ITT population definition                 58  
End of treatment visit too early                 33  
Lost to follow-up or no valid BP measure                 336  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects included in the study according to the study protocol i.e. patients who did not violate any inclusion or exclusion criteria

Reporting Groups
  Description
All Subjects

Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.

All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks.


Baseline Measures
    All Subjects  
Number of Participants  
[units: participants]
  2090  
Age [1]
[units: years]
Mean (Standard Deviation)
  54.78  (11.01)  
Gender [2]
[units: participants]
 
Female     808  
Male     1161  
[1] Age information was only collected for 1979 participants.
[2] Gender information was only collected for 1969 participants.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52   [ Time Frame: Up to 52 weeks ]

2.  Secondary:   Achieving JNC 7 Treatment Goals After Ramadan   [ Time Frame: 1 month ]

3.  Secondary:   Cardiovascular Events   [ Time Frame: Up to 52 weeks ]

4.  Secondary:   The Overall Assessment of Treatment by Patients at 52 Weeks   [ Time Frame: Up to 52 weeks ]

5.  Secondary:   The Overall Assessment of Treatment by Physicians at 52 Weeks   [ Time Frame: Up to 52 weeks ]

6.  Secondary:   Compliance of Patients up to 10 Days Before Ramadan   [ Time Frame: 10 days before Ramadan ]

7.  Secondary:   Compliance of Patients up to 10 Days After Ramadan   [ Time Frame: 10 days after Ramadan ]

8.  Secondary:   Compliance of Patients During the Whole Study Duration (52 Weeks)   [ Time Frame: Up to 52 weeks ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration   [ Time Frame: Up to 52 weeks ]

13.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


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
Results First Received: July 15, 2015
Last Updated: July 15, 2015
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