HypertensionNCT01853839

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

An observational study of Hypertension, run by Boehringer Ingelheim at 132 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
How many people: 1,674 participants
Where: 132 sitesin 5 countries
Study dates: Oct 2011to Jul 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Hypertensive patients wih at least one CV risk factor

Who may be able to join

Male or female of age 18 years or older;
Newly diagnosed and untreated or previously treated and uncontrolled patients with essential hypertension;
Seated blood pressure of >140/90 mmHg or >130/80 mmHg in patients with diabetes mellitus or chronic kidney disease;
Patients with at least one cardiovascular (cv) risk factor;
Ability to provide written informed consent.

Who cannot join

Patients with contraindications to the prescribed antihypertensive medications;
Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception;
Patients who are participating in any other study protocol.

Trial locations and contacts

132 sites in 5 countries.

Country

City, postcode or hospital

132 sites in 5 countries

Saudi Arabia35 sites

Boehringer Ingelheim Investigational Site 35
Dammam
Boehringer Ingelheim Investigational Site 36
Dammam
Boehringer Ingelheim Investigational Site 37
Dammam
Boehringer Ingelheim Investigational Site 38
Hofuf
Boehringer Ingelheim Investigational Site 50
Jeddah
Boehringer Ingelheim Investigational Site 51
Jeddah
Boehringer Ingelheim Investigational Site 52
Jeddah
Boehringer Ingelheim Investigational Site 53
Jeddah
Boehringer Ingelheim Investigational Site 54
Jeddah
Boehringer Ingelheim Investigational Site 55
Jeddah
Boehringer Ingelheim Investigational Site 56
Jeddah
Boehringer Ingelheim Investigational Site 57
Jeddah
Boehringer Ingelheim Investigational Site 58
Jeddah
Boehringer Ingelheim Investigational Site 59
Jeddah
Boehringer Ingelheim Investigational Site 60
Jeddah
Boehringer Ingelheim Investigational Site 61
Jeddah
Boehringer Ingelheim Investigational Site 62
Jeddah
Boehringer Ingelheim Investigational Site 63
Jeddah
Boehringer Ingelheim Investigational Site 64
Jeddah
Boehringer Ingelheim Investigational Site 65
Jeddah
Boehringer Ingelheim Investigational Site 32
Khobar
Boehringer Ingelheim Investigational Site 33
Khobar
Boehringer Ingelheim Investigational Site 34
Khobar
Boehringer Ingelheim Investigational Site 105
Riyadh
Boehringer Ingelheim Investigational Site 39
Riyadh
Boehringer Ingelheim Investigational Site 40
Riyadh
Boehringer Ingelheim Investigational Site 41
Riyadh
Boehringer Ingelheim Investigational Site 42
Riyadh
Boehringer Ingelheim Investigational Site 43
Riyadh
Boehringer Ingelheim Investigational Site 44
Riyadh
Boehringer Ingelheim Investigational Site 45
Riyadh
Boehringer Ingelheim Investigational Site 46
Riyadh
Boehringer Ingelheim Investigational Site 47
Riyadh
Boehringer Ingelheim Investigational Site 48
Riyadh
Boehringer Ingelheim Investigational Site 49
Riyadh

Other trials in Saudi Arabia

Egypt31 sites

Boehringer Ingelheim Investigational Site 29
Al Fayyum
Boehringer Ingelheim Investigational Site 15
Alexandria
Boehringer Ingelheim Investigational Site 19
Alexandria
Boehringer Ingelheim Investigational Site 21
Alexandria
Boehringer Ingelheim Investigational Site 22
Alexandria
Boehringer Ingelheim Investigational Site 23
Alexandria
Boehringer Ingelheim Investigational Site 3
Alexandria
Boehringer Ingelheim Investigational Site 6
Alexandria
Boehringer Ingelheim Investigational Site 18
Asyut
Boehringer Ingelheim Investigational Site 27
Asyut
Boehringer Ingelheim Investigational Site 11
Banisuif
Boehringer Ingelheim Investigational Site 10
Cairo
Boehringer Ingelheim Investigational Site 12
Cairo
Boehringer Ingelheim Investigational Site 13
Cairo
Boehringer Ingelheim Investigational Site 14
Cairo
Boehringer Ingelheim Investigational Site 17
Cairo
Boehringer Ingelheim Investigational Site 1
Cairo
Boehringer Ingelheim Investigational Site 20
Cairo
Boehringer Ingelheim Investigational Site 24
Cairo
Boehringer Ingelheim Investigational Site 25
Cairo
Boehringer Ingelheim Investigational Site 26
Cairo
Boehringer Ingelheim Investigational Site 28
Cairo
Boehringer Ingelheim Investigational Site 2
Cairo
Boehringer Ingelheim Investigational Site 4
Cairo
Boehringer Ingelheim Investigational Site 5
Cairo
Boehringer Ingelheim Investigational Site 7
Cairo
Boehringer Ingelheim Investigational Site 8
Cairo
Boehringer Ingelheim Investigational Site 9
Cairo
Boehringer Ingelheim Investigational Site 30
Domiat
Boehringer Ingelheim Investigational Site 16
Menia
Boehringer Ingelheim Investigational Site 31
Tanta

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Lebanon29 sites

Boehringer Ingelheim Investigational Site 66
Beirut
Boehringer Ingelheim Investigational Site 67
Beirut
Boehringer Ingelheim Investigational Site 68
Beirut
Boehringer Ingelheim Investigational Site 69
Beirut
Boehringer Ingelheim Investigational Site 70
Beirut
Boehringer Ingelheim Investigational Site 71
Beirut
Boehringer Ingelheim Investigational Site 72
Beirut
Boehringer Ingelheim Investigational Site 73
Beirut
Boehringer Ingelheim Investigational Site 74
Beirut
Boehringer Ingelheim Investigational Site 75
Beirut
Boehringer Ingelheim Investigational Site 76
Beirut
Boehringer Ingelheim Investigational Site 77
Beirut
Boehringer Ingelheim Investigational Site 78
Beirut
Boehringer Ingelheim Investigational Site 79
Beirut
Boehringer Ingelheim Investigational Site 80
Beirut
Boehringer Ingelheim Investigational Site 81
Beirut
Boehringer Ingelheim Investigational Site 82
Beirut
Boehringer Ingelheim Investigational Site 83
Beirut
Boehringer Ingelheim Investigational Site 84
Beirut
Boehringer Ingelheim Investigational Site 85
Beirut
Boehringer Ingelheim Investigational Site 86
Beirut
Boehringer Ingelheim Investigational Site 87
Beirut
Boehringer Ingelheim Investigational Site 88
Tripoli
Boehringer Ingelheim Investigational Site 89
Tripoli
Boehringer Ingelheim Investigational Site 90
Tripoli
Boehringer Ingelheim Investigational Site 91
Tripoli
Boehringer Ingelheim Investigational Site 92
Tripoli
Boehringer Ingelheim Investigational Site 93
Tripoli
Boehringer Ingelheim Investigational Site 94
Tripoli

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Algeria26 sites

Boehringer Ingelheim Investigational Site 106
Algiers
Boehringer Ingelheim Investigational Site 107
Algiers
Boehringer Ingelheim Investigational Site 108
Algiers
Boehringer Ingelheim Investigational Site 109
Algiers
Boehringer Ingelheim Investigational Site 110
Algiers
Boehringer Ingelheim Investigational Site 111
Algiers
Boehringer Ingelheim Investigational Site 112
Algiers
Boehringer Ingelheim Investigational Site 113
Algiers
Boehringer Ingelheim Investigational Site 114
Algiers
Boehringer Ingelheim Investigational Site 115
Algiers
Boehringer Ingelheim Investigational Site 116
Algiers
Boehringer Ingelheim Investigational Site 117
Algiers
Boehringer Ingelheim Investigational Site 118
Algiers
Boehringer Ingelheim Investigational Site 119
Algiers
Boehringer Ingelheim Investigational Site 120
Algiers
Boehringer Ingelheim Investigational Site 121
Algiers
Boehringer Ingelheim Investigational Site 122
Algiers
Boehringer Ingelheim Investigational Site 123
Algiers
Boehringer Ingelheim Investigational Site 124
Algiers
Boehringer Ingelheim Investigational Site 125
Algiers
Boehringer Ingelheim Investigational Site 126
Algiers
Boehringer Ingelheim Investigational Site 127
Algiers
Boehringer Ingelheim Investigational Site 128
Algiers
Boehringer Ingelheim Investigational Site 129
Algiers
Boehringer Ingelheim Investigational Site 130
Algiers
Boehringer Ingelheim Investigational Site 131
Algiers

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United Arab Emirates11 sites

Boehringer Ingelheim Investigational Site 100
Dubai
Boehringer Ingelheim Investigational Site 101
Dubai
Boehringer Ingelheim Investigational Site 102
Dubai
Boehringer Ingelheim Investigational Site 103
Dubai
Boehringer Ingelheim Investigational Site 104
Dubai
Boehringer Ingelheim Investigational Site 132
Dubai
Boehringer Ingelheim Investigational Site 95
Sharjah city
Boehringer Ingelheim Investigational Site 96
Sharjah city
Boehringer Ingelheim Investigational Site 97
Sharjah city
Boehringer Ingelheim Investigational Site 98
Sharjah city
Boehringer Ingelheim Investigational Site 99
Sharjah city

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About this study

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

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.

Read the detailed description

Purpose:

Conditions: Hypertension
Medical subject headings: Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 52 weeks

Secondary outcomes (12)

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.
Measured: 1 month
Cardiovascular Events
Percentage of participants who experienced a major cardiovascular (CV) event
Measured: Up to 52 weeks
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.
Measured: Up to 52 weeks
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.
Measured: Up to 52 weeks
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".
Measured: 10 days before Ramadan
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".
Measured: 10 days after Ramadan
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".
Measured: Up to 52 weeks
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)
Measured: Up to 52 weeks
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
Measured: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks
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
Measured: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks
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.
Measured: Up to 52 weeks
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.
Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Jul 2014

First posted15 May 2013 (estimated)
Study startOct 2011
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,674 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01853839
Sponsor's protocol ID: 502.602
Status last verified: Jul 2015
First submitted: 13 May 2013
Last updated: 10 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01853839
Acronym / sponsor ID: 502.602
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 1,674 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 15 May 2013 (estimated)
Results: Posted 10 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Purpose:

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hypertensive patients wih at least one CV risk factor

Key inclusion criteria (5 listed)

Male or female of age 18 years or older;
Newly diagnosed and untreated or previously treated and uncontrolled patients with essential hypertension;
Seated blood pressure of >140/90 mmHg or >130/80 mmHg in patients with diabetes mellitus or chronic kidney disease;
Patients with at least one cardiovascular (cv) risk factor;
Ability to provide written informed consent.

Key exclusion criteria (3 listed)

Patients with contraindications to the prescribed antihypertensive medications;
Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception;
Patients who are participating in any other study protocol.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

12 secondary outcomes

Achieving JNC 7 Treatment Goals After Ramadan
Time frame: 1 month
Cardiovascular Events
Time frame: Up to 52 weeks
The Overall Assessment of Treatment by Patients at 52 Weeks
Time frame: Up to 52 weeks
The Overall Assessment of Treatment by Physicians at 52 Weeks
Time frame: Up to 52 weeks
Compliance of Patients up to 10 Days Before Ramadan
Time frame: 10 days before Ramadan
Compliance of Patients up to 10 Days After Ramadan
Time frame: 10 days after Ramadan
Compliance of Patients During the Whole Study Duration (52 Weeks)
Time frame: Up to 52 weeks
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
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
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
The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration
Time frame: Up to 52 weeks
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

Results and safety

Results posted to the registry on 10 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	2,092	1,663

Primary outcome: Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52

Time frame: Up to 52 weeks. Number. Unit: Percentage of participants

Measure	All Subjects n = 1663
Yes	94.95
No	5.05

Population analysed: ITT dataset which included all patients, who received at least one dose of study medication.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until end of study, 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	21 of 2,090 (1%)	0 of 2,090 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

132 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 132 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in Saudi Arabia, Egypt, Lebanon, Algeria, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52 (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01853839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.