Trial Outcomes & Findings for Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients (NCT NCT01853839)

NCT ID: NCT01853839

Last Updated: 2015-08-10

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 1674 participants
• Primary outcome timeframe: Up to 52 weeks
• Results posted on: 2015-08-10

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	2092
Overall Study COMPLETED	1663
Overall Study NOT COMPLETED	429

Reasons for withdrawal

Measure	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.
Overall Study Violated inclusion criteria	2
Overall Study Not meet ITT population definition	58
Overall Study End of treatment visit too early	33
Overall Study Lost to follow-up or no valid BP measure	336

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Subjects n=2090 Participants 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.
Age, Continuous	54.78 years STANDARD_DEVIATION 11.01 • n=5 Participants
Gender Female	808 participants n=5 Participants
Gender Male	1161 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

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

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.

Outcome measures

Measure	All Subjects n=1663 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52 Yes	94.95 Percentage of participants	—
Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52 No	5.05 Percentage of participants	—

SECONDARY outcome

Timeframe: 1 month

Population: Per-protocol (PP) population which included all eligible patients who did not experience any protocol violation and were treated with the study medication up to week 52 (study completers) according to the prescribing information.

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.

Outcome measures

Measure	All Subjects n=1230 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting n=164 Participants 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
Achieving JNC 7 Treatment Goals After Ramadan Yes	87.07 Percentage of participants	85.97 Percentage of participants
Achieving JNC 7 Treatment Goals After Ramadan No	12.93 Percentage of participants	14.02 Percentage of participants

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: All subjects included in the study according to the study protocol i.e. patients who did not violate any inclusion or exclusion criteria

Percentage of participants who experienced a major cardiovascular (CV) event

Outcome measures

Measure	All Subjects n=2090 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
Cardiovascular Events	0.91 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Per-protocol population

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.

Outcome measures

Measure	All Subjects n=1548 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
The Overall Assessment of Treatment by Patients at 52 Weeks Outstanding	25.45 Percentage of participants	—
The Overall Assessment of Treatment by Patients at 52 Weeks Very satisfactory	53.88 Percentage of participants	—
The Overall Assessment of Treatment by Patients at 52 Weeks Satisfactory	18.80 Percentage of participants	—
The Overall Assessment of Treatment by Patients at 52 Weeks Marginal	1.42 Percentage of participants	—
The Overall Assessment of Treatment by Patients at 52 Weeks Not satisfactory	0.45 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Per-protocol population

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.

Outcome measures

Measure	All Subjects n=1548 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
The Overall Assessment of Treatment by Physicians at 52 Weeks Outstanding	25.97 Percentage of participants	—
The Overall Assessment of Treatment by Physicians at 52 Weeks Very satisfactory	55.49 Percentage of participants	—
The Overall Assessment of Treatment by Physicians at 52 Weeks Satisfactory	16.21 Percentage of participants	—
The Overall Assessment of Treatment by Physicians at 52 Weeks Marginal	1.74 Percentage of participants	—
The Overall Assessment of Treatment by Physicians at 52 Weeks Not satisfactory	0.58 Percentage of participants	—

SECONDARY outcome

Timeframe: 10 days before Ramadan

Population: Per-protocol population including all patients with data 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".

Outcome measures

Measure	All Subjects n=1788 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
Compliance of Patients up to 10 Days Before Ramadan None of the time	70.58 Percentage of participants	—
Compliance of Patients up to 10 Days Before Ramadan Some of the time	25.45 Percentage of participants	—
Compliance of Patients up to 10 Days Before Ramadan Most of the time	0.95 Percentage of participants	—
Compliance of Patients up to 10 Days Before Ramadan All the time	1.06 Percentage of participants	—
Compliance of Patients up to 10 Days Before Ramadan Do not know	1.96 Percentage of participants	—

SECONDARY outcome

Timeframe: 10 days after Ramadan

Population: Per-protocol population including all patients with data 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".

Outcome measures

Measure	All Subjects n=1748 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
Compliance of Patients up to 10 Days After Ramadan None of the time	71.11 Percentage of participants	—
Compliance of Patients up to 10 Days After Ramadan Some of the time	24.37 Percentage of participants	—
Compliance of Patients up to 10 Days After Ramadan Most of the time	2.40 Percentage of participants	—
Compliance of Patients up to 10 Days After Ramadan All the time	0.80 Percentage of participants	—
Compliance of Patients up to 10 Days After Ramadan Do not know	1.32 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Per-protocol population including all patients with data at 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".

Outcome measures

Measure	All Subjects n=1668 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
Compliance of Patients During the Whole Study Duration (52 Weeks) None of the time	70.68 Percentage of participants	—
Compliance of Patients During the Whole Study Duration (52 Weeks) Some of the time	25.78 Percentage of participants	—
Compliance of Patients During the Whole Study Duration (52 Weeks) Most of the time	1.98 Percentage of participants	—
Compliance of Patients During the Whole Study Duration (52 Weeks) All the time	0.48 Percentage of participants	—
Compliance of Patients During the Whole Study Duration (52 Weeks) Do not know	1.08 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Per-protocol population

Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)

Outcome measures

Measure	All Subjects n=864 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting n=382 Participants 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician) Yes	96.64 Percentage of participants	93.98 Percentage of participants
Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician) No	3.36 Percentage of participants	6.02 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks

Population: Per-protocol population

Change from baseline in systolic blood pressure before and after the month of Ramadan

Outcome measures

Measure	All Subjects n=1210 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting n=160 Participants 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
The Difference in Systolic Blood Pressure Before and After the Month of Ramadan 10 days before Ramadan (N=1200, 153)	24.4 mmHg Standard Deviation 16.7	25.0 mmHg Standard Deviation 16.3
The Difference in Systolic Blood Pressure Before and After the Month of Ramadan 10 days after Ramadan (N=1190, 160)	28.3 mmHg Standard Deviation 17.0	29.3 mmHg Standard Deviation 15.0
The Difference in Systolic Blood Pressure Before and After the Month of Ramadan 52 weeks (N=1210, 160)	30.3 mmHg Standard Deviation 17.2	30.6 mmHg Standard Deviation 15.9

SECONDARY outcome

Timeframe: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks

Population: Per-protocol population

Change from baseline in diastolic blood pressure before and after the month of Ramadan

Outcome measures

Measure	All Subjects n=1210 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting n=160 Participants 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan 10 days before Ramadan (N=1200, 153)	12.2 mmHg Standard Deviation 9.6	12.5 mmHg Standard Deviation 10.4
The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan 10 days after Ramadan (N=1190, 160)	14.4 mmHg Standard Deviation 9.6	15.1 mmHg Standard Deviation 9.2
The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan 52 weeks (N=1210, 160)	15.5 mmHg Standard Deviation 9.9	16.2 mmHg Standard Deviation 10.2

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Per-protocol population

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.

Outcome measures

Measure	All Subjects n=1578 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration Yes	85.93 Percentage of participants	—
The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration No	14.07 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: All subjects who took a combination of ARB and CCB drugs.

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.

Outcome measures

Measure	All Subjects n=518 Participants 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. Treatment duration is up to 52 weeks.	Non-Fasting 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. Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan.
Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs)	27 participants	—

Adverse Events

All Subjects

Serious events: 21 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Subjects n=2090 participants at risk 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.
Cardiac disorders Acute myocardial infarction	0.81% 17/2090 • From drug administration until end of study, 52 weeks
General disorders Accidental death	0.05% 1/2090 • From drug administration until end of study, 52 weeks
General disorders Sudden death	0.05% 1/2090 • From drug administration until end of study, 52 weeks
Nervous system disorders Cerebrovascular accident	0.10% 2/2090 • From drug administration until end of study, 52 weeks

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER