Trial Outcomes & Findings for Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension (NCT NCT01631227)

NCT ID: NCT01631227

Last Updated: 2014-07-25

Results Overview

Change from baseline of diastolic blood pressure (DBP), sitting

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 665 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2014-07-25

Participant Flow

Participant milestones

Measure	Eprosartan Eprosartan 450 mg + Placebo Eprosartan Mesylate	Eprosartan Mesylate Eprosartan Mesylate 600 mg + Placebo Eprosartan
Overall Study STARTED	333	332
Overall Study Safety Subject Sample	332	332
Overall Study Full Analysis Set Population	330	331
Overall Study COMPLETED	303	310
Overall Study NOT COMPLETED	30	22

Reasons for withdrawal

Measure	Eprosartan Eprosartan 450 mg + Placebo Eprosartan Mesylate	Eprosartan Mesylate Eprosartan Mesylate 600 mg + Placebo Eprosartan
Overall Study withdrawn consent	27	21
Overall Study Adverse Event	1	0
Overall Study administrative	2	1

Baseline Characteristics

Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension

Baseline characteristics by cohort

Measure	Eprosartan n=333 Participants Eprosartan 450 mg + Placebo Eprosartan Mesylate	Eprosartan Mesylate n=332 Participants Eprosartan Mesylate 600 mg + Placebo Eprosartan	Total n=665 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 10 • n=5 Participants	60 years STANDARD_DEVIATION 10 • n=7 Participants	60 years STANDARD_DEVIATION 10 • n=5 Participants
Gender Female	186 participants n=5 Participants	201 participants n=7 Participants	387 participants n=5 Participants
Gender Male	144 participants n=5 Participants	130 participants n=7 Participants	274 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Full analysis subject sample

Change from baseline of diastolic blood pressure (DBP), sitting

Outcome measures

Measure	Eprosartan n=330 Participants Eprosartan 450 mg + Placebo Eprosartan Mesylate	Eprosartan Mesylate n=331 Participants Eprosartan Mesylate 600 mg + Placebo Eprosartan
Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline	-7.4 mmHg Standard Deviation 7.7	-7.2 mmHg Standard Deviation 7.5

Adverse Events

Eprosartan

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Eprosartan Mesylate

Serious events: 7 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Eprosartan n=332 participants at risk Eprosartan 450 mg + Placebo Eprosartan Mesylate	Eprosartan Mesylate n=332 participants at risk Eprosartan Mesylate 600 mg + Placebo Eprosartan
Gastrointestinal disorders GASTRITIS HAEMORRHAGIC	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)
Injury, poisoning and procedural complications TIBIA FRACTURE	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)
Injury, poisoning and procedural complications FOREARM FRACTURE	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)
Nervous system disorders HEADACHE	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)
Nervous system disorders MIGRAINE	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)
Nervous system disorders DIZZINESS	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)
Endocrine disorders THYROID CYST	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)
General disorders CYSTIC RUPTURE	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)
Musculoskeletal and connective tissue disorders MENISCAL DEGENERATION	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)
Reproductive system and breast disorders POSTMENOPAUSAL HAEMORRHAGE	0.00% 0/332 • 15 weeks (3 run-in and 12 weeks treatment)	0.30% 1/332 • Number of events 1 • 15 weeks (3 run-in and 12 weeks treatment)

Other adverse events

Measure	Eprosartan n=332 participants at risk Eprosartan 450 mg + Placebo Eprosartan Mesylate	Eprosartan Mesylate n=332 participants at risk Eprosartan Mesylate 600 mg + Placebo Eprosartan
Infections and infestations NASOPHARYNGITIS	4.5% 15/332 • Number of events 15 • 15 weeks (3 run-in and 12 weeks treatment)	5.4% 18/332 • Number of events 18 • 15 weeks (3 run-in and 12 weeks treatment)

Additional Information

Associate Director Clinical Services

Abbott

Email: taco.baardman@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60