HypertensionPhase 4REVERENTNCT02499822
REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial
A Phase 4 study testing Nifedipine GITS and Ramipril in people with Hypertension and High Blood Pressure Variability, run by Istituto Auxologico Italiano at 3 sites in 3 countries.
Trial summary
The purpose of this study is 1. to compare the effects of nifedipine GITS and ramipril on blood pressure variability in subjects with elevated blood pressure variability. 2. to assess whether the degree of treatment-induced changes in blood pressure variability, is related to the degree of regression (or progression)… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hypertension, High Blood Pressure Variability
- What is being tested?
- Nifedipine GITS and Ramipril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2015to 1 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects
- Age 35-75 years
- Clinic systolic BP ≥140 mmHg and/or diastolic BP ≥ 90 mmHg (under no antihypertensive treatment)
- Daytime BP on ambulatory BP monitoring (ABPM) ≥135 mmHg systolic and/or ≥85 mmHg diastolic (under no antihypertensive treatment)
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
China1 site
Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital Shanghai Institute of Hypertension, Shanghai Jiaotong University School of Medicine
Shanghai
Greece1 site
Hypertension Center, Third University Department of Medicine, Sotiria Hospital
Athens
About this study
Official title: Short - Medium and Long Term Blood Pressure Variability in Essential Hypertensive Patients Treated With Nifedipine GITS or Ramipril - a Randomized Trial
The purpose of this study is
- to compare the effects of nifedipine GITS and ramipril on blood pressure variability in subjects with elevated blood pressure variability.
- 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 in heart, kidneys and carotid arteries.
Read the detailed description
Elevated blood pressure variability (BPV) is associated with adverse cardiovascular outcomes and organ damage in hypertensive subjects. An antihypertensive treatment able to reduce BPV independently of BP lowering effect might thus provide additional protection in terms of cardiovascular risk in subjects with elevated BPV, independently on its effect of BP itself. However, data on the effects of different classes of antihypertensive drugs on BPV are limited and inconsistent. Some studies have suggested a possible usefulness of calcium antagonists in this setting. Based on the above considerations the investigators hypothesize that a calcium channel blocker nifedipine GITS, will provide a greater BPV lowering effect, when compared with ramipril, independently from the reduction in mean BP level. Based on the above considerations, the primary objective of this study is to compare the effects of nifedipine GITS and ramipril on different estimates of BPV (24 h BPV, home BPV, and visit-to-visit BPV) in subjects with elevated BPV. The secondary objective is to assess whether the degree of treatment-induced changes in BPV, is related to the degree of regression (or progression) of organ damage, after accounting for mean BP reduction by treatment.
- Conditions
- Hypertension, High Blood Pressure Variability
- Being tested
- Nifedipine GITS, Ramipril
- Keywords
- Hypertension, Blood pressure variability, Home systolic blood pressure, Organ damage, Nifedipine GITS, Ramipril
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine GITSDrug
Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.
RamiprilDrug
Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine GITS 30 mg slow release | Experimental | Nifedipine GITS 30 mg slow release in tablets. Receives: Drug: Nifedipine GITS |
| Ramipril 10 mg | Experimental | Ramipril 10 mg in tablets. Receives: Drug: Ramipril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability (standard deviation) of home systolic blood pressure at final visit
Measured: After 10 weeks of study treatment
Secondary outcomes (13)
Variability (standard deviation) of home diastolic blood pressure measured at final visit
Measured: At baseline and after 10 weeks of study treatment
Short term 24h variability of systolic blood pressure at final visit (24h weighted standard deviation)
Measured: At baseline and after 10 weeks of study treatment
Short term 24h variability of diastolic blood pressure at final visit (24h weighted standard deviation)
Measured: 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
Measured: 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
Measured: At baseline and after 6, 8 and 10 weeks of study treatment
Mean 24 hour systolic blood pressure at final visit
Measured: At baseline and after 10 weeks of study treatment
Mean 24 hour diastolic blood pressure at final visit
Measured: At baseline and after 10 weeks of study treatment
Sokolow index at the end of the extension study
Measured: At baseline and after 12 months of study treatment
Cornell voltage duration index at the end of the extension study
Measured: At baseline and after 12 months of study treatment
Left ventricular mass index at the end of the extension study
Measured: At baseline and after 12 months of study treatment
Microalbuminuria (albumin-creatinine ratio) at the end of the extension study
Measured: At baseline and after 12 months of study treatment
Estimated glomerular filtration rate (eGFR, by CKD-EPI formula) at the end of the extension study
Measured: At baseline and after 12 months of study treatment
Carotid-femoral pulse wave velocity (cfPWV) at the end of the extension study
Measured: At baseline and after 12 months of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startOct 2015
- Primary completion3 Jul 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Gianfranco Parati, MD, Principal investigator, Istituto Auxologico Italiano - Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499822
- Sponsor's protocol ID
- 09F401
- Acronym
- REVERENT
- Status last verified
- Sep 2021
- First submitted
- 10 Jul 2015
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23817082Parati 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.
PubMed 23399972Liu JG, Xu LP, Chu ZX, Miao CY, Su DF. Contribution of blood pressure variability to the effect of nitrendipine on end-organ damage in spontaneously hypertensive rats. J Hypertens. 2003 Oct;21(10):1961-7. doi: 10.1097/00004872-200310000-00025.
PubMed 14508204Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlof B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X.
PubMed 20226988Webb AJ, Fischer U, Mehta Z, Rothwell PM. Effects of antihypertensive-drug class on interindividual variation in blood pressure and risk of stroke: a systematic review and meta-analysis. Lancet. 2010 Mar 13;375(9718):906-15. doi: 10.1016/S0140-6736(10)60235-8.
PubMed 20226989Ushigome E, Fukui M, Hamaguchi M, Tanaka T, Atsuta H, Ohnishi M, Oda Y, Yamazaki M, Hasegawa G, Nakamura N. Beneficial effect of calcium channel blockers on home blood pressure variability in the morning in patients with type 2 diabetes. J Diabetes Investig. 2013 Jul 8;4(4):399-404. doi: 10.1111/jdi.12052. Epub 2013 Mar 4.
PubMed 24843686Wang JG, Yan P, Jeffers BW. Effects of amlodipine and other classes of antihypertensive drugs on long-term blood pressure variability: evidence from randomized controlled trials. J Am Soc Hypertens. 2014 May;8(5):340-9. doi: 10.1016/j.jash.2014.02.004. Epub 2014 Feb 15.
PubMed 24685006Levi-Marpillat N, Macquin-Mavier I, Tropeano AI, Parati G, Maison P. Antihypertensive drug classes have different effects on short-term blood pressure variability in essential hypertension. Hypertens Res. 2014 Jun;37(6):585-90. doi: 10.1038/hr.2014.33. Epub 2014 Mar 27.
PubMed 24671016Mancia G, Facchetti R, Parati G, Zanchetti A. Visit-to-visit blood pressure variability in the European Lacidipine Study on Atherosclerosis: methodological aspects and effects of antihypertensive treatment. J Hypertens. 2012 Jun;30(6):1241-51. doi: 10.1097/HJH.0b013e32835339ac.
PubMed 22499291Matsui Y, O'Rourke MF, Hoshide S, Ishikawa J, Shimada K, Kario K. Combined effect of angiotensin II receptor blocker and either a calcium channel blocker or diuretic on day-by-day variability of home blood pressure: the Japan Combined Treatment With Olmesartan and a Calcium-Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study. Hypertension. 2012 Jun;59(6):1132-8. doi: 10.1161/HYPERTENSIONAHA.111.189217. Epub 2012 Apr 30.
PubMed 22547439Zhang W, Liu CY, Bilo G, Soranna D, Zambon A, Kyriakoulis KG, Kollias A, Ceravolo I, Cassago S, Pengo MF, Destounis A, Stergiou GS, Wang JG, Parati G. A Randomized Controlled Trial on the Efficacy and Safety of a Calcium-Channel Blocker and an Angiotensin-Converting Enzyme Inhibitor in Chinese and European Patients with Hypertension. Am J Hypertens. 2025 Mar 17;38(4):248-256. doi: 10.1093/ajh/hpae152.
PubMed 39657776
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short - Medium and Long Term Blood Pressure Variability in Essential Hypertensive Patients Treated With Nifedipine GITS or Ramipril - a Randomized Trial
- ClinicalTrials.gov ID
- NCT02499822
- Acronym / sponsor ID
- REVERENT / 09F401
- Conditions
- Hypertension, High Blood Pressure Variability
- Keywords
- Hypertension, Blood pressure variability, Home systolic blood pressure, Organ damage, Nifedipine GITS, Ramipril
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Oct 2015
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is
- to compare the effects of nifedipine GITS and ramipril on blood pressure variability in subjects with elevated blood pressure variability.
- 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 in heart, kidneys and carotid arteries.
Detailed description
Elevated blood pressure variability (BPV) is associated with adverse cardiovascular outcomes and organ damage in hypertensive subjects. An antihypertensive treatment able to reduce BPV independently of BP lowering effect might thus provide additional protection in terms of cardiovascular risk in subjects with elevated BPV, independently on its effect of BP itself. However, data on the effects of different classes of antihypertensive drugs on BPV are limited and inconsistent. Some studies have suggested a possible usefulness of calcium antagonists in this setting. Based on the above considerations the investigators hypothesize that a calcium channel blocker nifedipine GITS, will provide a greater BPV lowering effect, when compared with ramipril, independently from the reduction in mean BP level. Based on the above considerations, the primary objective of this study is to compare the effects of nifedipine GITS and ramipril on different estimates of BPV (24 h BPV, home BPV, and visit-to-visit BPV) in subjects with elevated BPV. The secondary objective is to assess whether the degree of treatment-induced changes in BPV, is related to the degree of regression (or progression) of organ damage, after accounting for mean BP reduction by treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine GITS 30 mg slow release | Experimental | Drug: Nifedipine GITSNifedipine GITS 30 mg slow release in tablets. |
| Ramipril 10 mg | Experimental | Drug: RamiprilRamipril 10 mg in tablets. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects
- Age 35-75 years
- Clinic systolic BP ≥140 mmHg and/or diastolic BP ≥ 90 mmHg (under no antihypertensive treatment)
- Daytime BP on ambulatory BP monitoring (ABPM) ≥135 mmHg systolic and/or ≥85 mmHg diastolic (under no antihypertensive treatment)
- Home SBP standard deviation (SD) >7 mmHg and/or daytime ambulatory SBP SD >12 mmHg
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine GITSCommercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os. | Drug | Nifedipine GITS 30 mg slow release |
| RamiprilCommercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os. | Drug | Ramipril 10 mg |
Primary outcome
Variability (standard deviation) of home systolic blood pressure at final visit
Time frame: After 10 weeks of study treatment
13 secondary outcomes
Variability (standard deviation) of home diastolic blood pressure measured at final visit
Time frame: At baseline and after 10 weeks of study treatment
Short term 24h variability of systolic blood pressure at final visit (24h weighted standard deviation)
Time frame: At baseline and after 10 weeks of study treatment
Short term 24h variability of diastolic blood pressure at final visit (24h weighted standard deviation)
Time frame: 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
Time frame: 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
Time frame: At baseline and after 6, 8 and 10 weeks of study treatment
Mean 24 hour systolic blood pressure at final visit
Time frame: At baseline and after 10 weeks of study treatment
Mean 24 hour diastolic blood pressure at final visit
Time frame: At baseline and after 10 weeks of study treatment
Sokolow index at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Cornell voltage duration index at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Left ventricular mass index at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Microalbuminuria (albumin-creatinine ratio) at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Estimated glomerular filtration rate (eGFR, by CKD-EPI formula) at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Carotid-femoral pulse wave velocity (cfPWV) at the end of the extension study
Time frame: At baseline and after 12 months of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Background: PubMed 23817082Mancia 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.
- Background: PubMed 23399972Parati 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.
- Background: PubMed 14508204Liu JG, Xu LP, Chu ZX, Miao CY, Su DF. Contribution of blood pressure variability to the effect of nitrendipine on end-organ damage in spontaneously hypertensive rats. J Hypertens. 2003 Oct;21(10):1961-7. doi: 10.1097/00004872-200310000-00025.
- Background: PubMed 20226988Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlof B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X.
- Background: PubMed 20226989Webb AJ, Fischer U, Mehta Z, Rothwell PM. Effects of antihypertensive-drug class on interindividual variation in blood pressure and risk of stroke: a systematic review and meta-analysis. Lancet. 2010 Mar 13;375(9718):906-15. doi: 10.1016/S0140-6736(10)60235-8.
- Background: PubMed 24843686Ushigome E, Fukui M, Hamaguchi M, Tanaka T, Atsuta H, Ohnishi M, Oda Y, Yamazaki M, Hasegawa G, Nakamura N. Beneficial effect of calcium channel blockers on home blood pressure variability in the morning in patients with type 2 diabetes. J Diabetes Investig. 2013 Jul 8;4(4):399-404. doi: 10.1111/jdi.12052. Epub 2013 Mar 4.
- Background: PubMed 24685006Wang JG, Yan P, Jeffers BW. Effects of amlodipine and other classes of antihypertensive drugs on long-term blood pressure variability: evidence from randomized controlled trials. J Am Soc Hypertens. 2014 May;8(5):340-9. doi: 10.1016/j.jash.2014.02.004. Epub 2014 Feb 15.
- Background: PubMed 24671016Levi-Marpillat N, Macquin-Mavier I, Tropeano AI, Parati G, Maison P. Antihypertensive drug classes have different effects on short-term blood pressure variability in essential hypertension. Hypertens Res. 2014 Jun;37(6):585-90. doi: 10.1038/hr.2014.33. Epub 2014 Mar 27.
- Background: PubMed 22499291Mancia G, Facchetti R, Parati G, Zanchetti A. Visit-to-visit blood pressure variability in the European Lacidipine Study on Atherosclerosis: methodological aspects and effects of antihypertensive treatment. J Hypertens. 2012 Jun;30(6):1241-51. doi: 10.1097/HJH.0b013e32835339ac.
- Background: PubMed 22547439Matsui Y, O'Rourke MF, Hoshide S, Ishikawa J, Shimada K, Kario K. Combined effect of angiotensin II receptor blocker and either a calcium channel blocker or diuretic on day-by-day variability of home blood pressure: the Japan Combined Treatment With Olmesartan and a Calcium-Channel Blocker Versus Olmesartan and Diuretics Randomized Efficacy Study. Hypertension. 2012 Jun;59(6):1132-8. doi: 10.1161/HYPERTENSIONAHA.111.189217. Epub 2012 Apr 30.
- Derived from this study: PubMed 39657776Zhang W, Liu CY, Bilo G, Soranna D, Zambon A, Kyriakoulis KG, Kollias A, Ceravolo I, Cassago S, Pengo MF, Destounis A, Stergiou GS, Wang JG, Parati G. A Randomized Controlled Trial on the Efficacy and Safety of a Calcium-Channel Blocker and an Angiotensin-Converting Enzyme Inhibitor in Chinese and European Patients with Hypertension. Am J Hypertens. 2025 Mar 17;38(4):248-256. doi: 10.1093/ajh/hpae152.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianfranco Parati, MD principal investigator
Istituto Auxologico Italiano - Milan, Italy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifedipine GITS and Ramipril in people with Hypertension and High Blood Pressure Variability, run by Istituto Auxologico Italiano at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Greece, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability (standard deviation) of home systolic blood pressure at final visit (time frame: After 10 weeks of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02499822, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.