Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01303445
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 4

Study Details

Study Description

Brief Summary

The objective of the current study is to investigate if a drug-drug interaction occurs with the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition (components of Aggrenox®) when administered every 12 hours at steady state.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Aggrenox alone; Drug: Aggrenox and omeprazole; Drug: Aggrenox and omeprazole; Drug: Omeprazole alone	Phase 1

Detailed Description

Purpose:

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Drug-drug Interaction Study of the Effect of Omeprazole 80 mg q.d. at Steady State on the Pharmacokinetics and Pharmacodynamics of Aggrenox® Every 12 Hours at Steady State in Healthy Male and Female Volunteers (an Open-label, Randomised, Crossover Study)
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment A Aggrenox alone	Drug: Aggrenox alone; Aggrenox 1 capsule twice daily for 7 days
Experimental: Treatment B Aggrenox and omeprazole	Drug: Aggrenox and omeprazole; Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
Active Comparator: Treatment C Omeprazole alone	Drug: Omeprazole alone; omeprazole 80 once daily for 7 days
Experimental: Treatment D Aggrenox and omeprazole	Drug: Aggrenox and omeprazole; Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days

Outcome Measures

Primary Outcome Measures

1. Plasma Dipyridamole Maximum Concentration (Cmax) [7 days]

   Maximum measured concentration of dipyridamole in plasma

2. Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) [7 days]

   Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state

3. Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4) [7 days]

   IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).

Secondary Outcome Measures

1. Plasma Dipyridamole Minimum Concentration (Cmin) [7 days]

   Minimum measured concentration of dipyridamole in plasma

2. Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12) [7 days]

   IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).

3. Percentage Peak-to-trough Fluctuation (%PTF) [7 days]

   PTF = 100*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

1. Healthy males and females according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (blood pressure(BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests

1. BMI >18.5 and BMI <32 kg/m2 (Body Mass Index)

Exclusion criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance in the opinion of the PI

2. Any evidence of a clinically relevant concomitant disease

3. Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, or hematologic (including a history of abnormal bruising) disorders in the opinion of the PI

4. Surgery of the gastrointestinal tract that might impair drug absorption

5. Clinically significant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

6. History of relevant orthostatic hypotension, fainting spells or blackouts.

7. Chronic or relevant acute infections

8. History of relevant allergy/hypersensitivity (including allergy to study drugs or its excipients, or reactions to related drugs [e.g., non-steroidal anti-inflammatory drugs])

9. Intake of drugs with a long half-life (¿24 hours) within one month, or less than 10 half lives of the respective drug, prior to study drug administration or during the trial

10. Use of drugs which might reasonably influence the results of the trial (including OTC antacids) based on the knowledge at the time of protocol preparation within 14 days prior to administration or during the trial

11. Participation in another trial with an investigational drug within two months prior to administration or during the trial

12. Tobacco use within the 90 days prior to check-in and throughout the study

13. Alcohol abuse within the past 2 years

14. Drug abuse within the past 2 years

15. Blood donation or other significant blood loss within 56 days (inclusive) prior to screening, or plasma donation within 7 days (inclusive) prior to study drug administration, or during the trial

16. Excessive physical activities (within one week prior to first drug administration or during the trial)

17. Any laboratory value outside the reference range that is of clinical relevance in the opinion of the PI; including positive virology, or urine drug screen, or positive fecal occult blood test

18. Inability to comply with dietary regimen of trial site

19. In the opinion of the investigator it would be in the best interest of the subject to be excluded from participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	9.197.001 Boehringer Ingelheim Investigational Site	Tempe	Arizona	United States

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01303445
• Other Study ID Numbers: 9.197
• First Posted: Feb 24, 2011
• Last Update Posted: Dec 24, 2013
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Omeprazole; Aspirin, Dipyridamole Drug Combination

Study Results

Participant Flow

Arm/Group Title	ABCD Sequence	CDAB Sequence
Arm/Group Description	Aggrenox/Aggrenox+Omeprazole/Omeprazole/Aggrenox+Omeprazole	Omeprazole/Aggrenox+Omeprazole/Aggrenox/Aggrenox+Omeprazole
Period Title: First Intervention (7 Days)
STARTED	30	30
COMPLETED	29	30
NOT COMPLETED	1	0
Period Title: First Intervention (7 Days)
STARTED	29	30
COMPLETED	28	28
NOT COMPLETED	1	2
Period Title: First Intervention (7 Days)
STARTED	28	28
COMPLETED	27	26
NOT COMPLETED	1	2
Period Title: First Intervention (7 Days)
STARTED	27	26
COMPLETED	27	26
NOT COMPLETED	0	0
Period Title: First Intervention (7 Days)
STARTED	27	26
COMPLETED	26	26
NOT COMPLETED	1	0
Period Title: First Intervention (7 Days)
STARTED	26	26
COMPLETED	26	25
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description
Overall Participants	60
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	35.3
Sex: Female, Male (Count of Participants)
Female	18 30%
Male	42 70%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	48 80%
Not Hispanic or Latino	12 20%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (participants) [Number]
White	57 95%
Black / African American	3 5%
Weight (kilograms) [Mean (Full Range) ]
Mean (Full Range) [kilograms]	75.69
Body Mass Index (BMI) (kilograms per square meter) [Mean (Full Range) ]
Mean (Full Range) [kilograms per square meter]	26.81

Outcome Measures

1. Primary Outcome

Title	Plasma Dipyridamole Maximum Concentration (Cmax)
Description	Maximum measured concentration of dipyridamole in plasma
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.

Arm/Group Title	Aggrenox Alone BID	Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone	Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone	Omeprazole Alone QD
Arm/Group Description	Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone	Omeprazole 40mg QD (once daily)
Measure Participants	55	54	54	0
Geometric Mean (Geometric Coefficient of Variation) [nanogram/milliliter]	2750 (30.4)	2550 (27.5)	2550 (29.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone
	Comments	Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	92.03
	Confidence Interval	() 90%; 86.95 to 97.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone
	Comments	Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	92.30
	Confidence Interval	() 90%; 87.76 to 97.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)
Description	Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.

Arm/Group Title	Aggrenox Alone BID	Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone	Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone	Omeprazole Alone QD
Arm/Group Description	Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone	Omeprazole 40mg QD (once daily)
Measure Participants	55	53	54	0
Geometric Mean (Geometric Coefficient of Variation) [(nanogram/milliliter)*hours]	17100 (33.7)	16700 (28.4)	16500 (31.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone
	Comments	Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	96.38
	Confidence Interval	() 90%; 90.96 to 102.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone
	Comments	Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	97.03
	Confidence Interval	() 95%; 93.26 to 100.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)
Description	IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.

Arm/Group Title	Aggrenox Alone BID	Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone	Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone	Omeprazole Alone QD
Arm/Group Description	Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone	Omeprazole 40mg QD (once daily)
Measure Participants	55	54	54	0
Mean (Standard Deviation) [percent of baseline platelet aggregation]	97.89 (2.74)	96.34 (4.21)	97.02 (2.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone
	Comments	Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	99.02
	Confidence Interval	() 90%; 98.32 to 99.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone
	Comments	Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	98.42
	Confidence Interval	() 90%; 97.66 to 99.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Plasma Dipyridamole Minimum Concentration (Cmin)
Description	Minimum measured concentration of dipyridamole in plasma
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.

Arm/Group Title	Aggrenox Alone BID	Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone	Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone	Omeprazole Alone QD
Arm/Group Description	Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone	Omeprazole 40mg QD (once daily)
Measure Participants	55	54	54	0
Geometric Mean (Geometric Coefficient of Variation) [nanogram/milliliter]	679 (47.1)	723 (41.8)	713 (46.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone
	Comments	Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	105.55
	Confidence Interval	() 90%; 97.09 to 114.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone
	Comments	Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	106.09
	Confidence Interval	() 90%; 98.64 to 114.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)
Description	IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.

Arm/Group Title	Aggrenox Alone BID	Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone	Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone	Omeprazole Alone QD
Arm/Group Description	Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone	Omeprazole 40mg QD (once daily)
Measure Participants	55	54	54	0
Mean (Standard Deviation) [percent of baseline platelet aggregation]	98.78 (2.53)	97.80 (3.00)	98.11 (2.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone
	Comments	Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	99.38
	Confidence Interval	() 90%; 98.80 to 99.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aggrenox Alone BID, Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone
	Comments	Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percent Mean Ratio
	Estimated Value	99.02
	Confidence Interval	() 90%; 98.46 to 99.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage Peak-to-trough Fluctuation (%PTF)
Description	PTF = 100*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.

Arm/Group Title	Aggrenox Alone BID	Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone	Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone	Omeprazole Alone QD
Arm/Group Description	Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone	Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone	Omeprazole 40mg QD (once daily)
Measure Participants	55	53	54	0
Mean (Standard Deviation) [percent of average hourly plasma conc.]	144 (31.8)	132 (41.4)	134 (41.2)

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Aggrenox Alone BID		Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone		Omeprazole Alone QD		Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone
Arm/Group Description	Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)		Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone		Omeprazole 40mg QD (once daily)		Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
All Cause Mortality
	Aggrenox Alone BID		Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone		Omeprazole Alone QD		Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Aggrenox Alone BID		Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone		Omeprazole Alone QD		Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/55 (0%)		0/57 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Aggrenox Alone BID		Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone		Omeprazole Alone QD		Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/56 (73.2%)		15/55 (27.3%)		17/57 (29.8%)		48/57 (84.2%)
Cardiac disorders
Palpitations	3/56 (5.4%)		0/55 (0%)		2/57 (3.5%)		2/57 (3.5%)
Gastrointestinal disorders
Abdominal pain	3/56 (5.4%)		0/55 (0%)		1/57 (1.8%)		0/57 (0%)
Diarrhoea	6/56 (10.7%)		4/55 (7.3%)		2/57 (3.5%)		6/57 (10.5%)
Flatulence	0/56 (0%)		1/55 (1.8%)		3/57 (5.3%)		0/57 (0%)
Nausea	19/56 (33.9%)		0/55 (0%)		4/57 (7%)		14/57 (24.6%)
Vomiting	12/56 (21.4%)		2/55 (3.6%)		2/57 (3.5%)		14/57 (24.6%)
General disorders
Chest discomfort	6/56 (10.7%)		1/55 (1.8%)		1/57 (1.8%)		4/57 (7%)
Chills	1/56 (1.8%)		1/55 (1.8%)		3/57 (5.3%)		1/57 (1.8%)
Injury, poisoning and procedural complications
Contusion	3/56 (5.4%)		2/55 (3.6%)		1/57 (1.8%)		2/57 (3.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/56 (3.6%)		1/55 (1.8%)		4/57 (7%)		0/57 (0%)
Myalgia	18/56 (32.1%)		4/55 (7.3%)		2/57 (3.5%)		20/57 (35.1%)
Neck pain	3/56 (5.4%)		0/55 (0%)		2/57 (3.5%)		1/57 (1.8%)
Nervous system disorders
Dizziness	7/56 (12.5%)		3/55 (5.5%)		2/57 (3.5%)		10/57 (17.5%)
Headache	39/56 (69.6%)		6/55 (10.9%)		7/57 (12.3%)		41/57 (71.9%)
Paraesthesia	3/56 (5.4%)		0/55 (0%)		2/57 (3.5%)		1/57 (1.8%)
Somnolence	1/56 (1.8%)		1/55 (1.8%)		4/57 (7%)		1/57 (1.8%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	7/56 (12.5%)		1/55 (1.8%)		0/57 (0%)		1/57 (1.8%)
Skin and subcutaneous tissue disorders
Pruritus generalised	0/56 (0%)		2/55 (3.6%)		1/57 (1.8%)		3/57 (5.3%)
Urticaria	0/56 (0%)		0/55 (0%)		0/57 (0%)		3/57 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.