Study of the efficacy of two blood pressure lowering drugs, ramipril and nifedipine GITS, in reducing the variability of blood pressure in patients with high blood pressure.

• Conditions: essential hypertension; MedDRA version: 18.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-003459-76-GR
• Lead Sponsor: Istituto Auxologico Italiano, IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-27
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

- Male and female subjects
- Age 35-75 years
- clinic systolic (SBP) =140 mmHg and/or diastolic blood pressure (DBP) = 90 mmHg
- daytime blood pressure (BP) on ambulatory BP monitoring (ABPM) =135 mmHg systolic and/or =85 mmHg diastolic
- home SBP standard deviation (SD) >7 mmHg and/or daytime ambulatory SBP SD >12 mmHg
- patients may be included if untreated or, if treated with one antihypertensive drug or two drugs in low doses, after 2 weeks’ washout period
- written informed consent to participate in the study
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

- subjects treated with = 2 antihypertensive drugs (except those on two drugs in low doses)
- treated subjects with on-treatment clinic BP =160 mmHg systolic and/or 100 mmHg diastolic
- treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical for other reasons
- Contraindications to study treatments as detailed in the relative Summaries of medical Product Characteristics for ramipril or nifedipine GITS (this includes hypersensitivity, pregnancy and lactation)
- Cardiovascular diseases other than hypertension (coronary heart disease, heart failure or left ventricular systolic dysfunction of any degree, atrial fibrillation or frequent arrhythmias, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, aortic aneurysm)
- Chronic kidney disease
- Suspected or confirmed secondary hypertension
- Diabetes mellitus
- Subjects with conditions other than those mentioned above, where compelling indications for the use of any specific class of antihypertensive medication exist, according to current (e.g. European Society of Cardiology) guidelines
- Other conditions deemed relevant by the investigator
- BMI =35 kg/m2
- known severe obstructive sleep apnea
- Premenopausal women not using effective contraceptive methods
- Elevated probability of noncompliance with the study procedures

Study & Design

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