Hypertension
Conditions
Brief summary
The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.
Detailed description
This Phase 2 study EPLA-0501-072 (A6141012) was conducted beginning 02 April 2003 and was prematurely terminated due to poor enrollment on 12 September 2003. There were no statistical analyses of efficacy conducted because the numbers of patients enrolled were insufficient for inferential analysis due to the poor enrollment. There were no serious adverse events or deaths reported during the study.
Interventions
DRUGeplerenone
Eplerenone 50 mg oral film-coated tablet once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to eplerenone 100 mg oral film-coated tablet once daily for 4 weeks.
DRUGLosartan
Losartan 50 mg oral capsule once daily for 8 weeks. If blood pressure was uncontrolled (DBP ≥ 90 mmHg) at Week 4, the dose was increased to losartan 100 mg oral capsule once daily for 4 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of mild to moderate hypertension, or newly diagnosed hypertension, defined as seDBP ≥90 mmHg and \<110 mmHg and seSBP \<180 mmHg * Withdrawal of all previous antihypertensives prior to the single-blind placebo run-in period and the double-blind treatment period
Exclusion criteria
* Secondary hypertension (e.g., renal, renovascular, or adrenocortical disease, pheochromocytoma, Cushing's syndrome, primary aldosteronism, iatrogenic), severe hypertension, or malignant hypertension * The patient cannot withdraw from antihypertensives by any route including diuretics, alpha-blockers, betablockers, calcium channel blockers, ACE-I, ARB, or other medications affecting blood pressure; patients who have stable angina and have not had their nitrate dosage changed within the past three months (i.e., on a stable maintenance dose) are eligible for this study; sildenafil citrate, theophylline, or papaverine must not be taken within 24 hours prior to a clinic visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8 | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8 | 8 weeks |
| Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of ≥10 mmHg in DBP | 8 weeks |
| Overall safety and tolerability of all treatments as assessed by change in vital signs, 12-lead electrocardiograms, clinical laboratory tests, and adverse events | 8 weeks |
Countries
Taiwan
Outcome results
None listed