HypertensionPhase 4NCT03106597
Manidipine Versus Amlodipine in Patients With Hypertension
A Phase 4 study testing Manidipine 20mg and Amlodipine 10mg in people with Hypertension, run by Korea University Guro Hospital at 3 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of a third-generation Calcium Channel Blocker (CCB), manidipine, compared with second-generation Calcium Channel Blocker (CCB), amlodipine, on the development of peripheral edema using Direct Segmental Multi-Frequency Bioelectrical Impedance Analysis (DSM-BIA) method… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Manidipine 20mg and Amlodipine 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 20 Aug 2015to 14 Aug 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female outpatients between the ages of 20 and 80 years with uncomplicated essential hypertension are eligible.
- Inclusion criteria requires that patients have either stage I or stage II hypertension (mean sitting systolic Blood Pressure (BP) 140-179 mmHg, diastolic BP 90-109 mmHg).
- The patients are newly diagnosed or known hypertensive subjects who were not taking antihypertensive agents for more than the last 4 weeks.
Who cannot join
- Patients are excluded from the study if they have any evidence of clinically significant concurrent medical conditions including cardiac, renal, hepatic, gastrointestinal, or endocrinologic disease.
- Patients are also excluded if they have known hypersensitivity or serious drug reactions to Calcium Channel Blockers (CCBs), any evidence of prior deep vein thrombosis, lymphatic disease, or concurrent requirement for medications that could affect Blood Pressure (BP) or salt and water retention (e.g, nonsteroidal antinflammatory drugs, estrogen containing drugs).
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Yonsei University Severance Hospital
Seoul, 03722
Korea University Guro Hospital
Seoul, 08308
Yonsei University Wonju Hospital
Wŏnju, 26426
About this study
Official title: Manidipine Versus Amlodipine in Patients With Hypertension: Effects on Peripheral Edema Evaluated by Bioimpedance Analysis
The purpose of this study is to evaluate the effect of a third-generation Calcium Channel Blocker (CCB), manidipine, compared with second-generation Calcium Channel Blocker (CCB), amlodipine, on the development of peripheral edema using Direct Segmental Multi-Frequency Bioelectrical Impedance Analysis (DSM-BIA) method in patients with mild to moderate essential hypertension. Investigator expects this study could show more objective evidence of better safety of manidipine compared with amlodipine for peripheral edema.
Read the detailed description
Dihydropyridine Calcium Channel Blockers (CCBs) are one of the most commonly used potent antihypertensive agents. Their vasodilatory effects are associated with Adverse Effects (AEs) such as peripheral edema, headache and flushing.
The incidence of peripheral edema with Calcium Channel Blocker (CCB) is 6% in a recent systematic review and is clearly dose-dependent and more common in women, in obese and in elderly hypertensives. Peripheral edema could be a cause for poor persistence with therapy or antihypertensive treatment withdrawal and has a deleterious impact on health-related quality of life.
A recent meta-analysis of head-to-head trials to compare the efficacy and safety profile of manidipine and amlodipine showed significantly better safety of manidipine: the Relative Risk (RR) for adverse event was 0.69 (0.56-0.85), and particularly for ankle edema Relative Risk (RR) was 0.35 (0.22-0.54).
Although peripheral edema is an important issue in Calcium Channel Blocker (CCB) treatment, techniques (e.g, ankle-foot volume using a water displacement measurement, plethysmography, and pretibial subcutaneous tissue pressure) for the objective measurement are not generally available in a clinical setting. Most clinical studies relied on self-report of peripheral edema that is not a reliable objective method.
Recently, Bioelectrical Impedance Analysis (BIA) has become increasingly popular for estimating body composition, including Extracellular Water (ECW) and Intracellular Water (ICW), fat mass and fat-free mass. Mechanistically, the Calcium Channel Blocker (CCB)-related peripheral edema is likely due to distal arteriolar dilatation with capillary leak to tissue spaces. Because BIA method can measure the edema as the ratio of Extracellular Water (ECW) to Total Body Water (TBW), it may reflect the Calcium Channel Blocker (CCB)-related edema. Moreover, the Direct Segmental Multi-frequency Bioelectrical Impedance Analysis (DSM-BIA) has been validated to assess segmental body (i.e., trunk, arms and legs) composition in addition to total body composition and can provide segmental edema score as well as total edema score. This new, previously not reported method is expected to provide more objective and precise data for peripheral edema.
- Conditions
- Hypertension
- Being tested
- Manidipine 20mg, Amlodipine 10mg
- Keywords
- Peripheral Edema, Bioimpedance Analysis
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manidipine 20mgDrug
Also called Madipine Tab(Manidipine Hydrochloride) 20mg (CJ)
After a 1~2-week run-in period, patents will be randomized to receive manidipine (20 mg/day; n=50) for a 8-week open-labeled phase. Study drugs will be administered orally and once daily between 8:00am and 10:00am.
BP, heart rate, adverse events and concomitant therapy are assessed and a physical examination is performed at each visit. A 12-lead standard ECG is obtained and hematology, clinical biochemistry and urine analysis investigations performed at the screening visit. A Bioelectrical Impedance Analysis (BIA) is undertaken at the screening visit and at the end of the 8-week treatment course. Patients have to attend the clinic visit every 4 weeks during the treatment period.
Amlodipine 10mgDrug
Also called Amlodipine Pfizer 10mg (Pfizer)
After a 1~2-week run-in period, patents will be randomized to receive amlodipine (10 mg/day; n=50) for a 8-week open-labeled phase. Study drugs will be administered orally and once daily between 8:00am and 10:00am.
BP, heart rate, adverse events and concomitant therapy are assessed and a physical examination is performed at each visit. A 12-lead standard ECG is obtained and hematology, clinical biochemistry and urine analysis investigations performed at the screening visit. A Bioelectrical Impedance Analysis (BIA) is undertaken at the screening visit and at the end of the 8-week treatment course. Patients have to attend the clinic visit every 4 weeks during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Manidipine 20mg | Experimental | 50 patients will be administered orally manidipine 20mg/day after 1~2 week run-in period Receives: Drug: Manidipine 20mg |
| Amlodipine 10mg | Active comparator | 50 patients will be administered orally amlodipine 10mg/day after 1~2 week run-in period Receives: Drug: Amlodipine 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in leg edema score (Extracellular Water(ECW) to Total Body Water(TBW))
Measured: Up to 8 weeks
Secondary outcomes (3)
Changes in segmental (each arm/leg, trunk) edema score
Measured: Up to 8 weeks
Changes in Blood Pressure (BP)
Measured: Up to 8 weeks
Incidences of AEs
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start20 Aug 2015
- Primary completion15 May 2018
- Study completion14 Aug 2019
Why it stopped: Difficulty in enrolling subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Model description
- 1. Manidipine 20mg/day, Amlodipine 10mg/day 2. Sealed envelope method randomization according to gender and age * 25 males under 55 years old * 25 males more than 55 years old * 25 females under 55 years old * 25 females more than 55 years old
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals International, Inc.
- Responsible party
- Principal investigator, Eung Ju Kim, Korea University Guro Hospital
- Investigators
- Eung Ju Kim, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106597
- Sponsor's protocol ID
- KUGH15082 (MAAMA)
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2017
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richy FF, Laurent S. Efficacy and safety profiles of manidipine compared with amlodipine: a meta-analysis of head-to-head trials. Blood Press. 2011 Feb;20(1):54-9. doi: 10.3109/08037051.2010.518670. Epub 2010 Oct 14.
PubMed 20945994Opie LH. Calcium channel antagonists. Part IV: Side effects and contraindications drug interactions and combinations. Cardiovasc Drugs Ther. 1988 Jul;2(2):177-89. doi: 10.1007/BF00051233.
PubMed 3154704Makani H, Bangalore S, Romero J, Wever-Pinzon O, Messerli FH. Effect of renin-angiotensin system blockade on calcium channel blocker-associated peripheral edema. Am J Med. 2011 Feb;124(2):128-35. doi: 10.1016/j.amjmed.2010.08.007.
PubMed 21295192Messerli FH, Oparil S, Feng Z. Comparison of efficacy and side effects of combination therapy of angiotensin-converting enzyme inhibitor (benazepril) with calcium antagonist (either nifedipine or amlodipine) versus high-dose calcium antagonist monotherapy for systemic hypertension. Am J Cardiol. 2000 Dec 1;86(11):1182-7. doi: 10.1016/s0002-9149(00)01199-1.
PubMed 11090788Fogari R. Ankle oedema and sympathetic activation. Drugs. 2005;65 Suppl 2:21-7. doi: 10.2165/00003495-200565002-00004.
PubMed 16398059Weir MR, Rosenberger C, Fink JC. Pilot study to evaluate a water displacement technique to compare effects of diuretics and ACE inhibitors to alleviate lower extremity edema due to dihydropyridine calcium antagonists. Am J Hypertens. 2001 Sep;14(9 Pt 1):963-8. doi: 10.1016/s0895-7061(01)02167-7.
PubMed 11587165Fogari R, Malamani G, Zoppi A, Mugellini A, Rinaldi A, Fogari E, Perrone T. Effect on the development of ankle edema of adding delapril to manidipine in patients with mild to moderate essential hypertension: a three-way crossover study. Clin Ther. 2007 Mar;29(3):413-8. doi: 10.1016/s0149-2918(07)80079-8.
PubMed 17577462Seo HS, Kim EJ, Kim SW, Im SI, Na JO, Choi CU, Lim HE, Won Kim J, Rha SW, Park CG. Extracellular fluid adjusted for body size is contracted in hypertension. Hypertens Res. 2013 Oct;36(10):916-21. doi: 10.1038/hr.2013.68. Epub 2013 Jul 11.
PubMed 23842617Ling CH, de Craen AJ, Slagboom PE, Gunn DA, Stokkel MP, Westendorp RG, Maier AB. Accuracy of direct segmental multi-frequency bioimpedance analysis in the assessment of total body and segmental body composition in middle-aged adult population. Clin Nutr. 2011 Oct;30(5):610-5. doi: 10.1016/j.clnu.2011.04.001. Epub 2011 May 8.
PubMed 21555168Schoeller DA, Alon A, Manekas D, Mixson LA, Lasseter KC, Noonan GP, Bolognese JA, Heymsfield SB, Beals CR, Nunes I. Segmental bioimpedance for measuring amlodipine-induced pedal edema: a placebo-controlled study. Clin Ther. 2012 Mar;34(3):580-92. doi: 10.1016/j.clinthera.2012.01.018. Epub 2012 Mar 3.
PubMed 22385927
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manidipine Versus Amlodipine in Patients With Hypertension: Effects on Peripheral Edema Evaluated by Bioimpedance Analysis
- ClinicalTrials.gov ID
- NCT03106597
- Acronym / sponsor ID
- KUGH15082 (MAAMA)
- Conditions
- Hypertension
- Keywords
- Peripheral Edema, Bioimpedance Analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling subjects
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals International, Inc.
- Study start
- 20 Aug 2015 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 10 Apr 2017 (actual)
- 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 evaluate the effect of a third-generation Calcium Channel Blocker (CCB), manidipine, compared with second-generation Calcium Channel Blocker (CCB), amlodipine, on the development of peripheral edema using Direct Segmental Multi-Frequency Bioelectrical Impedance Analysis (DSM-BIA) method in patients with mild to moderate essential hypertension. Investigator expects this study could show more objective evidence of better safety of manidipine compared with amlodipine for peripheral edema.
Detailed description
Dihydropyridine Calcium Channel Blockers (CCBs) are one of the most commonly used potent antihypertensive agents. Their vasodilatory effects are associated with Adverse Effects (AEs) such as peripheral edema, headache and flushing.
The incidence of peripheral edema with Calcium Channel Blocker (CCB) is 6% in a recent systematic review and is clearly dose-dependent and more common in women, in obese and in elderly hypertensives. Peripheral edema could be a cause for poor persistence with therapy or antihypertensive treatment withdrawal and has a deleterious impact on health-related quality of life.
A recent meta-analysis of head-to-head trials to compare the efficacy and safety profile of manidipine and amlodipine showed significantly better safety of manidipine: the Relative Risk (RR) for adverse event was 0.69 (0.56-0.85), and particularly for ankle edema Relative Risk (RR) was 0.35 (0.22-0.54).
Although peripheral edema is an important issue in Calcium Channel Blocker (CCB) treatment, techniques (e.g, ankle-foot volume using a water displacement measurement, plethysmography, and pretibial subcutaneous tissue pressure) for the objective measurement are not generally available in a clinical setting. Most clinical studies relied on self-report of peripheral edema that is not a reliable objective method.
Recently, Bioelectrical Impedance Analysis (BIA) has become increasingly popular for estimating body composition, including Extracellular Water (ECW) and Intracellular Water (ICW), fat mass and fat-free mass. Mechanistically, the Calcium Channel Blocker (CCB)-related peripheral edema is likely due to distal arteriolar dilatation with capillary leak to tissue spaces. Because BIA method can measure the edema as the ratio of Extracellular Water (ECW) to Total Body Water (TBW), it may reflect the Calcium Channel Blocker (CCB)-related edema. Moreover, the Direct Segmental Multi-frequency Bioelectrical Impedance Analysis (DSM-BIA) has been validated to assess segmental body (i.e., trunk, arms and legs) composition in addition to total body composition and can provide segmental edema score as well as total edema score. This new, previously not reported method is expected to provide more objective and precise data for peripheral edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1. Manidipine 20mg/day, Amlodipine 10mg/day 2. Sealed envelope method randomization according to gender and age * 25 males under 55 years old * 25 males more than 55 years old * 25 females under 55 years old * 25 females more than 55 years old
| Arm | Type | Receives |
|---|---|---|
| Manidipine 20mg | Experimental | Drug: Manidipine 20mg50 patients will be administered orally manidipine 20mg/day after 1~2 week run-in period |
| Amlodipine 10mg | Active comparator | Drug: Amlodipine 10mg50 patients will be administered orally amlodipine 10mg/day after 1~2 week run-in period |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female outpatients between the ages of 20 and 80 years with uncomplicated essential hypertension are eligible.
- Inclusion criteria requires that patients have either stage I or stage II hypertension (mean sitting systolic Blood Pressure (BP) 140-179 mmHg, diastolic BP 90-109 mmHg).
- The patients are newly diagnosed or known hypertensive subjects who were not taking antihypertensive agents for more than the last 4 weeks.
Key exclusion criteria (2 listed)
- Patients are excluded from the study if they have any evidence of clinically significant concurrent medical conditions including cardiac, renal, hepatic, gastrointestinal, or endocrinologic disease.
- Patients are also excluded if they have known hypersensitivity or serious drug reactions to Calcium Channel Blockers (CCBs), any evidence of prior deep vein thrombosis, lymphatic disease, or concurrent requirement for medications that could affect Blood Pressure (BP) or salt and water retention (e.g, nonsteroidal antinflammatory drugs, estrogen containing drugs).
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 |
|---|---|---|
| Manidipine 20mgAlso: Madipine Tab(Manidipine Hydrochloride) 20mg (CJ)After a 1~2-week run-in period, patents will be randomized to receive manidipine (20 mg/day; n=50) for a 8-week open-labeled phase. Study drugs will be administered orally and once daily between 8:00am and 10:00am. BP, heart rate, adverse events and concomitant therapy are assessed and a physical examination is performed at each visit. A 12-lead standard ECG is obtained and hematology, clinical biochemistry and urine analysis investigations performed at the screening visit. A Bioelectrical Impedance Analysis (BIA) is undertaken at the screening visit and at the end of the 8-week treatment course. Patients have to attend the clinic visit every 4 weeks during the treatment period. | Drug | Manidipine 20mg |
| Amlodipine 10mgAlso: Amlodipine Pfizer 10mg (Pfizer)After a 1~2-week run-in period, patents will be randomized to receive amlodipine (10 mg/day; n=50) for a 8-week open-labeled phase. Study drugs will be administered orally and once daily between 8:00am and 10:00am. BP, heart rate, adverse events and concomitant therapy are assessed and a physical examination is performed at each visit. A 12-lead standard ECG is obtained and hematology, clinical biochemistry and urine analysis investigations performed at the screening visit. A Bioelectrical Impedance Analysis (BIA) is undertaken at the screening visit and at the end of the 8-week treatment course. Patients have to attend the clinic visit every 4 weeks during the treatment period. | Drug | Amlodipine 10mg |
Primary outcome
Change in leg edema score (Extracellular Water(ECW) to Total Body Water(TBW))
Time frame: Up to 8 weeks
3 secondary outcomes
Changes in segmental (each arm/leg, trunk) edema score
Time frame: Up to 8 weeks
Changes in Blood Pressure (BP)
Time frame: Up to 8 weeks
Incidences of AEs
Time frame: Up to 8 weeks
Results and safety
The study was stopped early (reason given: Difficulty in enrolling subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Background: PubMed 20945994Richy FF, Laurent S. Efficacy and safety profiles of manidipine compared with amlodipine: a meta-analysis of head-to-head trials. Blood Press. 2011 Feb;20(1):54-9. doi: 10.3109/08037051.2010.518670. Epub 2010 Oct 14.
- Background: PubMed 3154704Opie LH. Calcium channel antagonists. Part IV: Side effects and contraindications drug interactions and combinations. Cardiovasc Drugs Ther. 1988 Jul;2(2):177-89. doi: 10.1007/BF00051233.
- Background: PubMed 21295192Makani H, Bangalore S, Romero J, Wever-Pinzon O, Messerli FH. Effect of renin-angiotensin system blockade on calcium channel blocker-associated peripheral edema. Am J Med. 2011 Feb;124(2):128-35. doi: 10.1016/j.amjmed.2010.08.007.
- Background: PubMed 11090788Messerli FH, Oparil S, Feng Z. Comparison of efficacy and side effects of combination therapy of angiotensin-converting enzyme inhibitor (benazepril) with calcium antagonist (either nifedipine or amlodipine) versus high-dose calcium antagonist monotherapy for systemic hypertension. Am J Cardiol. 2000 Dec 1;86(11):1182-7. doi: 10.1016/s0002-9149(00)01199-1.
- Background: PubMed 16398059Fogari R. Ankle oedema and sympathetic activation. Drugs. 2005;65 Suppl 2:21-7. doi: 10.2165/00003495-200565002-00004.
- Background: PubMed 11587165Weir MR, Rosenberger C, Fink JC. Pilot study to evaluate a water displacement technique to compare effects of diuretics and ACE inhibitors to alleviate lower extremity edema due to dihydropyridine calcium antagonists. Am J Hypertens. 2001 Sep;14(9 Pt 1):963-8. doi: 10.1016/s0895-7061(01)02167-7.
- Background: PubMed 17577462Fogari R, Malamani G, Zoppi A, Mugellini A, Rinaldi A, Fogari E, Perrone T. Effect on the development of ankle edema of adding delapril to manidipine in patients with mild to moderate essential hypertension: a three-way crossover study. Clin Ther. 2007 Mar;29(3):413-8. doi: 10.1016/s0149-2918(07)80079-8.
- Background: PubMed 23842617Seo HS, Kim EJ, Kim SW, Im SI, Na JO, Choi CU, Lim HE, Won Kim J, Rha SW, Park CG. Extracellular fluid adjusted for body size is contracted in hypertension. Hypertens Res. 2013 Oct;36(10):916-21. doi: 10.1038/hr.2013.68. Epub 2013 Jul 11.
- Background: PubMed 21555168Ling CH, de Craen AJ, Slagboom PE, Gunn DA, Stokkel MP, Westendorp RG, Maier AB. Accuracy of direct segmental multi-frequency bioimpedance analysis in the assessment of total body and segmental body composition in middle-aged adult population. Clin Nutr. 2011 Oct;30(5):610-5. doi: 10.1016/j.clnu.2011.04.001. Epub 2011 May 8.
- Background: PubMed 22385927Schoeller DA, Alon A, Manekas D, Mixson LA, Lasseter KC, Noonan GP, Bolognese JA, Heymsfield SB, Beals CR, Nunes I. Segmental bioimpedance for measuring amlodipine-induced pedal edema: a placebo-controlled study. Clin Ther. 2012 Mar;34(3):580-92. doi: 10.1016/j.clinthera.2012.01.018. Epub 2012 Mar 3.
- Individual participant dataSharing planned: No
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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.
Eung Ju Kim, MD principal investigator
Professor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Manidipine 20mg and Amlodipine 10mg in people with Hypertension, run by Korea University Guro Hospital at 3 sites in South Korea.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 4 Sep 2020. 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 South Korea. 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 was stopped early (reason given: Difficulty in enrolling subjects). Results are not available in the source record.
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?
Change in leg edema score (Extracellular Water(ECW) to Total Body Water(TBW)) (time frame: Up to 8 weeks). 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 NCT03106597, which also lists 10 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 4 Sep 2020.