Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension
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ClinicalTrials.gov Identifier: NCT01631227 |
Recruitment Status :
Completed
First Posted : June 29, 2012
Results First Posted : May 26, 2014
Last Update Posted : July 25, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Essential Hypertension | Drug: Eprosartan Drug: Eprosartan Mesylate Drug: Placebo Eprosartan mesylate Drug: Placebo Eprosartan | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | June 2012 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Eprosartan
Eprosartan + Placebo Eprosartan Mesylate
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Drug: Eprosartan
Eprosartan 450 mg Drug: Placebo Eprosartan mesylate Placebo Eprosartan mesylate
Other Name: Placebo |
Active Comparator: Eprosartan Mesylate
Eprosartan Mesylate + Placebo Eprosartan
|
Drug: Eprosartan Mesylate
Eprosartan mesylate 600 mg
Other Names:
Drug: Placebo Eprosartan Placebo Eprosartan
Other Name: Placebo |
- 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 [ Time Frame: 8 weeks ]Change from baseline of diastolic blood pressure (DBP), sitting

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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%)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631227

Study Director: | Dmitri N. Kazei, MD | Abbott Healthcare Products B.V. |
Responsible Party: | Abbott |
ClinicalTrials.gov Identifier: | NCT01631227 |
Other Study ID Numbers: |
M13-385 2010-019432-12 ( EudraCT Number ) |
First Posted: | June 29, 2012 Key Record Dates |
Results First Posted: | May 26, 2014 |
Last Update Posted: | July 25, 2014 |
Last Verified: | July 2014 |
Hypertension Essential Hypertension Vascular Diseases Cardiovascular Diseases Eprosartan |
Antihypertensive Agents Angiotensin II Type 2 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |