A Study to Compare the Effect of Eprosartan versus Eprosartan Mesylate on Blood Pressure in Subjects with High Blood Presure

Phase 1

• Conditions: Essential Hypertension; MedDRA version: 14.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-019155-22-GB
• Lead Sponsor: Abbott Healthcare Products B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-15
• Study Completion: 2013-04-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 596

Inclusion Criteria

1. Male or female aged = 18 years

2. Subjects with history of mild to moderate essential hypertension for at least 2 months and with mean sitting SBP = 140 mmHg and = 179 mmHg; and mean sitting DBP = 90 mmHg and = 109 mmHg at screening (V1) and at baseline (V2)

3. Written informed consent to participate in the study before starting any study-specific procedures at V1 (screening)

4. Compliance with the study medication > 80% and < 120% during the 3-week placebo washout period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 358
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 238

Exclusion Criteria

1. Women of childbearing potential without hormonal, barrier or intrauterine contraception methods

2. Inability to discontinue all prior antihypertensive medications safely for the duration of the washout period, subjects on triple combination of antihypertensive drugs at V1 or subjects on dual combination with moderate hypertension (SBP=160-179 mmHg and/or DBP =100-109 mmHg) at V1

3. Pregnant or breast-feeding female subject

4. Any secondary form of hypertension

5. Severe (Grade 3) hypertension (SBP = 180 mmHg and/or DBP = 110 mmHg)

6. Presence of the differences greater than 20mmHg for SBP and 10mmHg for DPB on 3 consecutive readings at V1 or V2

7. Angina pectoris that is currently being treated with long acting nitrates, beta-blockers, or calcium channel blockers unless kept on stable doses for the duration of the study

8. Severe diabetes mellitus (HbA1c greater 8.5%) with metabolic complications (diabetic ketoacidosis, hyperosmolar hyperglycemia associated with dehydration)

9. Nonresponders to ACE inhibitors or angiotensin receptor blockers (ARBs), however, subjects known to be intolerant to ACE inhibitors are allowed except for a low-dose aspirin (75-325mg
per day)

10. Concomitant administration of lithium and NSAIDs except for a low-dose aspirin (75-325mg per day)

11. New York Heart Association (NYHA) Class IV congestive heart failure

12. Myocardial infarction or unstable angina within the preceding 90 days

13. Aortic and mitral valve stenosis, hypertrophic cardiomyopathy

14. Known or suspected hemo-dynamically significant bilateral renal artery stenosis or severe stenosis of a solitary functioning kidney

15. Severe renal impairment (creatinine clearance < 30 mL/min)

16. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2 times the upper limit of normal and/or total bilirubin > 3 mg/dL

17. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

18. Active alcohol or drug abuse

19. Known hypersensitivity to the active substances of eprosartan or to any of its excipients, or to sulfonamide derived substances (such as HCTZ)

20. Administration of an investigational drug or device, or participation in an investigational trial within 30 days

21. Clinically significant laboratory abnormalities or medical conditions which, in the opinion of the Investigator, make them unsuitable for evaluation

22. Subjects withdrawn from the study cannot re-enter this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Change in trough sitting DBP from baseline to end of Week 8.;Timepoint(s) of evaluation of this end point: 8 weeks;Main Objective: To assess the therapeutic equivalence of eprosartan (a new formulation containing only the active moiety eprosartan) with eprosartan mesylate (currently marketed formulation) on sitting diastolic blood pressure (DBP) in ambulatory subjects with mild to moderate essential hypertension after 8 weeks of treatment (monotherapy).;Secondary Objective: To compare the effect of eprosartan with eprosartan mesylate on sitting systolic blood pressure (SBP), responder rate, and normalization rate after 8 weeks (monotherapy) and 12 weeks (add-on therapy) of treatment, and on sitting trough blood pressure at 12 weeks.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Change in trough sitting SBP from baseline (V2) to end of Week 8 (V4).<br> 2. Change in trough sitting DBP and trough sitting SBP from baseline (V2) to end of Week 12 (V5).<br> 3. Responder rate at Week 8 (V4) and at Week 12 (V5) on monotherapy.<br> 4. Normalization rate at Week 8 (V4) and Week 12 (V5) on monotherapy.<br> 5. Responder rate at Week 12 (V5) in subjects with add-on HCTZ.<br> 6. Normalization rate at Week 12 (V5) in subjects with add-on HCTZ.<br> ;Timepoint(s) of evaluation of this end point: 8 and/or 12 Weeks