Essential Hypertension
Conditions
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.
Interventions
DRUGEprosartan
Eprosartan 450 mg
DRUGEprosartan Mesylate
Eprosartan mesylate 600 mg
DRUGPlacebo Eprosartan mesylate
Placebo Eprosartan mesylate
DRUGPlacebo Eprosartan
Placebo Eprosartan
Sponsors
Quintiles, Inc.
Synexus
author! et al. BV
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany, Russia, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eprosartan Eprosartan 450 mg + Placebo Eprosartan Mesylate | 333 |
| Eprosartan Mesylate Eprosartan Mesylate 600 mg + Placebo Eprosartan | 332 |
| Total | 665 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | administrative | 2 | 1 |
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | withdrawn consent | 27 | 21 |
Baseline characteristics
| Characteristic | Eprosartan | Eprosartan Mesylate | Total |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 10 | 60 years STANDARD_DEVIATION 10 | 60 years STANDARD_DEVIATION 10 |
| Gender Female | 186 participants | 201 participants | 387 participants |
| Gender Male | 144 participants | 130 participants | 274 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 332 | 18 / 332 |
| serious Total, serious adverse events | 3 / 332 | 7 / 332 |
Outcome results
Primary
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
Change from baseline of diastolic blood pressure (DBP), sitting
Time frame: 8 weeks
Population: Full analysis subject sample
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 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 |
| Eprosartan Mesylate | 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 | -7.2 mmHg | Standard Deviation 7.5 |