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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01631227
• Collaborator: Quintiles, Inc. (Industry), Synexus (Other), author! et al. BV (Other)
• Enrollment: 665
• Locations: 38
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 17.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: Eprosartan; Drug: Eprosartan Mesylate; Drug: Placebo Eprosartan mesylate; Drug: Placebo Eprosartan	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 665 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized Double-blind Parallel Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects With Mild to Moderate Essential Hypertension
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eprosartan Eprosartan + Placebo Eprosartan Mesylate	Drug: Eprosartan; Eprosartan 450 mg; Drug: Placebo Eprosartan mesylate; Placebo Eprosartan mesylate; Other Names: Placebo
Active Comparator: Eprosartan Mesylate Eprosartan Mesylate + Placebo Eprosartan	Drug: Eprosartan Mesylate; Eprosartan mesylate 600 mg; Other Names: ABT-139 Teveten ; Drug: Placebo Eprosartan; Placebo Eprosartan; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. 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 [8 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Males or females with essential hypertension, blood pressure values between 140 mmHg and 179 mmHg systolic and between 90 mmHg and 109 mmHg diastolic

• Given written informed consent prior to starting the study

Exclusion Criteria

• Women with childbearing potential, breast feeding or pregnant;

• Inability to discontinue all prior antihypertensive medication;

• Secondary hypertension

• Severe hypertension

• Severe diabetes mellitus (HbA1c greater 8.5%)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 74062	Berlin		Germany	12627
2	Site Reference ID/Investigator# 74066	Bochum		Germany	44787
3	Site Reference ID/Investigator# 74065	Dresden		Germany	01067
4	Site Reference ID/Investigator# 93513	Dresden		Germany	01307
5	Site Reference ID/Investigator# 93495	Essen		Germany	45355
6	Site Reference ID/Investigator# 93515	Frankfurt		Germany	60594
7	Site Reference ID/Investigator# 74060	Frankfurt		Germany	60596
8	Site Reference ID/Investigator# 74063	Goerlitz		Germany	02826
9	Site Reference ID/Investigator# 93494	Hamburg		Germany	22143
10	Site Reference ID/Investigator# 93493	Karlsruhe		Germany	76199
11	Site Reference ID/Investigator# 74061	Leipzig		Germany	04103
12	Site Reference ID/Investigator# 74064	Magdeburg		Germany	39104
13	Site Reference ID/Investigator# 93514	Nuremberg		Germany	90402
14	Site reference ID/Investigator # 82515	Barnaul		Russian Federation	656055
15	Site reference ID/Investigator # 82520	Kazan		Russian Federation	420012
16	Site reference ID/Investigator # 82493	Kemerovo		Russian Federation	650002
17	Site reference ID/Investigator # 82516	Kemerovo		Russian Federation	650055
18	Site refernce ID/Investigator # 82521	Krasnodar		Russian Federation	350086
19	Site reference ID/Investigator # 82495	Novosibirsk		Russian Federation	630008
20	Site reference ID/Investigator # 82494	Novosibirsk		Russian Federation	630047
21	Site reference ID/Investigator # 82525	Novosibirsk		Russian Federation	630068
22	Site reference ID/Investigator # 82522	St. Petersburg		Russian Federation	192283
23	Site reference ID/Investigator # 82517	St. Petersburg		Russian Federation	194044
24	Site reference ID/Investigator # 82524	St. Petersburg		Russian Federation	197022
25	Site reference ID/Investiragor # 82523	St. Petersburg		Russian Federation	197022
26	Site reference ID/Investigator # 82519	St. Petersburg		Russian Federation	198205
27	Site reference ID/Investigator # 82518	St. Petersburg		Russian Federation	198260
28	Site reference ID/Investigator # 82527	St. Petersburg		Russian Federation	199106
29	Site Reference ID/Investigator# 74057	Birmingham		United Kingdom	B15 2SQ
30	Site Reference ID/Investigator# 74059	Cardiff		United Kingdom	CF14 5GJ
31	Site Reference ID/Investigator# 74056	Chorley		United Kingdom	PR7 7NA
32	Site Reference ID/Investigator# 74054	Glasgow		United Kingdom	G20 0SP
33	Site reference ID/Investigator # 95456	Glasgow		United Kingdom	G45 9AW
34	Site Reference ID/Investigator# 74053	Liverpool		United Kingdom	L22 0LG
35	Site reference ID/Investigator # 95457	London		United Kingdom	EC1M 6BQ
36	Site Reference ID/Investigator# 74055	Manchester		United Kingdom	M16 6SX
37	Site reference ID/Investigator # 95455	Northwood		United Kingdom	HA6 2RN
38	Site Reference ID/Investigator# 74058	Reading		United Kingdom	RG2 0TG

Sponsors and Collaborators

• Abbott
• Quintiles, Inc.
• Synexus
• author! et al. BV

Investigators

• Study Director: Dmitri N. Kazei, MD, Abbott Healthcare Products B.V.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01631227
• Other Study ID Numbers: M13-385; 2010-019432-12
• First Posted: Jun 29, 2012
• Last Update Posted: Jul 25, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Eprosartan

Study Results

Participant Flow

Arm/Group Title	Eprosartan	Eprosartan Mesylate
Arm/Group Description	Eprosartan 450 mg + Placebo Eprosartan Mesylate	Eprosartan Mesylate 600 mg + Placebo Eprosartan
Period Title: Overall Study
STARTED	333	332
Safety Subject Sample	332	332
Full Analysis Set Population	330	331
COMPLETED	303	310
NOT COMPLETED	30	22

Baseline Characteristics

Arm/Group Title	Eprosartan	Eprosartan Mesylate	Total
Arm/Group Description	Eprosartan 450 mg + Placebo Eprosartan Mesylate	Eprosartan Mesylate 600 mg + Placebo Eprosartan	Total of all reporting groups
Overall Participants	333	332	665
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (10)	60 (10)	60 (10)
Gender (participants) [Number]
Female	186 55.9%	201 60.5%	387 58.2%
Male	144 43.2%	130 39.2%	274 41.2%

Outcome Measures

1. Primary Outcome

Title	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
Description	Change from baseline of diastolic blood pressure (DBP), sitting
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Full analysis subject sample

Arm/Group Title	Eprosartan	Eprosartan Mesylate
Arm/Group Description	Eprosartan 450 mg + Placebo Eprosartan Mesylate	Eprosartan Mesylate 600 mg + Placebo Eprosartan
Measure Participants	330	331
Least Squares Mean (Standard Deviation) [mmHg]	-7.4 (7.7)	-7.2 (7.5)

Adverse Events

Time Frame	15 weeks (3 run-in and 12 weeks treatment)
Arm/Group Title	Eprosartan		Eprosartan Mesylate
Arm/Group Description	Eprosartan 450 mg + Placebo Eprosartan Mesylate		Eprosartan Mesylate 600 mg + Placebo Eprosartan
All Cause Mortality
	Eprosartan		Eprosartan Mesylate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Eprosartan		Eprosartan Mesylate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/332 (0.9%)		7/332 (2.1%)
Endocrine disorders
THYROID CYST	0/332 (0%)	0	1/332 (0.3%)	1
Gastrointestinal disorders
GASTRITIS HAEMORRHAGIC	0/332 (0%)	0	1/332 (0.3%)	1
GASTROOESOPHAGEAL REFLUX DISEASE	0/332 (0%)	0	1/332 (0.3%)	1
General disorders
CYSTIC RUPTURE	0/332 (0%)	0	1/332 (0.3%)	1
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION	1/332 (0.3%)	1	0/332 (0%)	0
Injury, poisoning and procedural complications
TIBIA FRACTURE	1/332 (0.3%)	1	0/332 (0%)	0
FOREARM FRACTURE	0/332 (0%)	0	1/332 (0.3%)	1
Musculoskeletal and connective tissue disorders
MENISCAL DEGENERATION	0/332 (0%)	0	1/332 (0.3%)	1
Nervous system disorders
HEADACHE	0/332 (0%)	0	1/332 (0.3%)	1
MIGRAINE	1/332 (0.3%)	1	0/332 (0%)	0
DIZZINESS	0/332 (0%)	0	1/332 (0.3%)	1
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE	0/332 (0%)	0	1/332 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Eprosartan		Eprosartan Mesylate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/332 (4.5%)		18/332 (5.4%)
Infections and infestations
NASOPHARYNGITIS	15/332 (4.5%)	15	18/332 (5.4%)	18

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.