A Prospective Open-label, Multicentric, Phase IV Trial to Compare the Efficacy of 10-Week Therapy of Ramipril and Indapamide SR Tablets Given Concomitantly with that of the Monotherapy of Ramipril or Indapamide SR in the Treatment of Hypertensive Patients whose Blood Pressure is Not Controlled by Monotherapy

Phase 1

• Conditions: hypertension; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-001030-34-HU
• Lead Sponsor: Egis Pharmaceuticals PLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-04
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

1.Mild and moderate (Grade 1 and 2) essential hypertension not controlled at ramipril or indapamide SR monotherapy administered at least 4 weeks. Definition of not controlled mild and moderate hypertension: systolic blood pressure [SBP] = 140 mmHg with or without diastolic blood pressure [DBP] = 90 mmHg, but SBP = 179 mmHg and DBP = 109 mmHg.
2.Male and female patients = 18 years, but < 80 years of age.
3.Medically accepted effective contraception for women of childbearing potential (WOCBP) and it should be continued until at least 90 days after the last dose of trial treatment).
4.Patients capable to give consent and who have signed the Informed Consent Form before any trial related assessment

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 203
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

1.General contraindications of thiazide diuretics and/or ACE inhibitors
a)Known hypersensitivity to indapamide or other sulphonamides, ramipril or any other ACE inhibitor or to any of the excipients
b)History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs)
c)Secondary hypertension
d)Extracorporeal treatments leading to contact of blood with negatively charged surfaces
e)Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
f)Renal impairment defined as eGFR < 60 ml/min
g)Hepatic encephalopathy or impairment of liver function. i.e. ASAT and/or ALAT = 2 ULN, GGT = 2 ULN
h)Hypokalaemia, i.e. se Potassium < LLN
i)Hyperkalaemia, i.e. se Potassium > ULN
j)Hyponatraemia i.e. se Sodium < LLN
k)Hypercalcaemia i.e. se Calcium > ULN
l)Hyperuricemia i.e. se uric acid > ULN and judged clinically significant
m)Congestive heart failure (NYHA III-IV.)
n)Type 1 or uncontrolled Type 2 diabetes mellitus, i.e. HbA1C >8%, or patients on SGLT2 inhibitor treatment.
o)Treatment with ARB, aliskiren or lithium
p)Patients with hypotensive or haemodynamically unstable states
q)Patients having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident (stroke), acute heart failure or transient ischaemic attack within the last six months

2.Any other anti-hypertensive drugs (other than ramipril and indapamide SR) used within 4 weeks prior to the screening visit.
3.Use of any enzyme-modifying drugs acting on cytochrome P450 (CYP) 3A4 enzymes via inhibition or induction within 28 days before day 1 of this trial.
4.Elderly patients < 80 years of age, but not in good physical and mental condition, who in the opinion of the Investigator will not tolerate reduction of BP until target of 140/80 mmHg (fragile” elderly patients)
5.Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, lactose intolerance or glucose-galactose malabsorption
6.History of drug or alcohol dependency or abuse within the last 2 years
7.Concurrent alcohol and/or drug abuse.

8.Any other condition, disease or therapy which in the Investigator’s opinion would pose a risk to the subject or interfere with the trial objectives.

9.Pregnancy and lactation period. All female patients with reproductive potential must have a negative pregnancy serum test at the time of the Screening visit and have to use adequate contraception during the study.

10.Known lack of subject compliance.

11.Participation in another clinical trial within the previous 30 days.

12.Persons directly involved in the execution of this protocol and their relatives.
Females of childbearing potential must have negative serum pregnancy test at screening. (All females will be considered to be of childbearing potential unless they are postmenopausal i.e. amenorrhoeic for at least 12 consecutive months, in the appropriate age group and without other known or suspected cause or have been sterilized surgically i.e. bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing.)

Study & Design

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