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 hypertensionMedDRA version: 17.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-003459-76-IT
- Lead Sponsor
- Istituto Auxologico Italiano, IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 168
- 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
- 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
- Suspected or confirmed secondary hypertension
- Diabetes mellitus
- 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
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effects of nifedipine GITS and ramipril on different estimates of blood pressure variability (over 24 h, at home, between clinic visits) in subjects with elevated blood pressure variability.;Secondary Objective: To assess whether the degree of treatment-induced changes in blood pressure variability, is related to the degree of regression (or progression) of organ damage, after accounting for mean blood pressure reduction by treatment.;Primary end point(s): Variability (standard deviation) of home systolic blood pressure.;Timepoint(s) of evaluation of this end point: Final visit of the main study (10 weeks after randomization)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Variability (standard deviation) of home diastolic blood pressure.<br>2) Short term 24h variability of systolic blood pressure at final visit<br>3) Short term 24h variability of diastolic blood pressure at final visit<br>4) Visit-to-visit variability of systolic blood pressure assessed over the three last visits<br>5) Visit-to-visit variability of diastolic blood pressure assessed over the three last visits<br>6) Mean 24 hour systolic blood pressure at final visit;Timepoint(s) of evaluation of this end point: Secondary endpoints 1, 2, 3 and 6: Final visit of the main study (10 weeks after randomization)<br>Secondary endpoints 4 and 5: The last three visits of the main study (6, 8 and 10 weeks after randomization)