Trials Sponsors Conditions Drugs Pricing

Conditions

High Blood Pressure Variability Hypertension

Keywords

HypertensionBlood pressure variabilityHome systolic blood pressureOrgan damageNifedipine GITSRamipril

Outcome Measures

Primary Outcomes (1)

Variability (standard deviation) of home systolic blood pressure at final visit
After 10 weeks of study treatment

Secondary Outcomes (13)

Variability (standard deviation) of home diastolic blood pressure measured at final visit
At baseline and after 10 weeks of study treatment
Short term 24h variability of systolic blood pressure at final visit (24h weighted standard deviation)
At baseline and after 10 weeks of study treatment
Short term 24h variability of diastolic blood pressure at final visit (24h weighted standard deviation)
At baseline and after 10 weeks of study treatment
Visit-to-visit variability (standard deviation) of systolic blood pressure assessed over the three last visits
At baseline and after 6, 8 and 10 weeks of study treatment
Visit-to-visit variability (standard deviation) of diastolic blood pressure assessed over the three last visits
At baseline and after 6, 8 and 10 weeks of study treatment
+8 more secondary outcomes

Study Arms (2)

Nifedipine GITS 30 mg slow release

EXPERIMENTAL

Nifedipine GITS 30 mg slow release in tablets.

Drug: Nifedipine GITS

Ramipril 10 mg

EXPERIMENTAL

Ramipril 10 mg in tablets.

Drug: Ramipril

Interventions

Nifedipine GITSDrug

Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.

Nifedipine GITS 30 mg slow release

RamiprilDrug

Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.

Ramipril 10 mg

Eligibility Criteria

Age35 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male and female subjects
Age 35-75 years

Sponsors & Collaborators

Istituto Auxologico Italiano
Otherlead
Bayer
Industrycollaborator

Study Sites (3)

Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital Shanghai Institute of Hypertension, Shanghai Jiaotong University School of Medicine

Shanghai, China

Hypertension Center, Third University Department of Medicine, Sotiria Hospital

Athens, Greece

Istituto Auxologico Italiano

Milan, Italy

Related Publications (11)

Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
PMID: 23817082BACKGROUND
Parati G, Ochoa JE, Lombardi C, Bilo G. Assessment and management of blood-pressure variability. Nat Rev Cardiol. 2013 Mar;10(3):143-55. doi: 10.1038/nrcardio.2013.1. Epub 2013 Feb 12.
PMID: 23399972

MeSH Terms

Conditions

Hypertension

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Gianfranco Parati, MD
Istituto Auxologico Italiano - Milan, Italy
PRINCIPAL INVESTIGATOR

Enrollment

168 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 10, 2015

First Posted

July 16, 2015

Study Start

October 2015

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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 by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
Contraindications to study treatments as detailed in the relative Summaries of Medical Product Characteristics for ramipril (hypersensitivity to ramipril or any of the excipients or any other ACE inhibitor, history of angioneurotic oedema, extracorporeal treatments leading to contact of blood with negatively charged surfaces, significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, second and third trimesters of pregnancy, lactation, haemodynamically relevant renal artery stenosis, hypotensive or haemodynamically unstable patients) or nifedipine GITS (known hypersensitivity to nifedipine or to any of the excipients, pregnancy before week 20 and during breastfeeding, cardiovascular shock, concomitant treatment with rifampicin, patients with a Kock pouch)
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 (including respiratory disorders, liver disease, renal disease, thyroid disorders)
BMI ≥35 kg/m2
Known severe obstructive sleep apnea (apnea-hypopnea index \> 30 or use of CPAP)
Premenopausal women not using effective contraceptive methods
Elevated probability of noncompliance with the study procedures

REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Nifedipine GITS 30 mg slow release

Ramipril 10 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Nifedipine GITS 30 mg slow release

Ramipril 10 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations