Cardiac EdemaPhase 3NCT01651156
Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema
A Phase 3 study testing Tolvaptan in people with Cardiac Edema, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
A randomized, double-blind, multicenter, placebo-controlled, parallel study to evaluate the efficacy and safety of Tolvaptan in the treatment of patients with cardiac edema (body fluid retention caused by congestive heart failure) based on the conventional therapy. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cardiac Edema
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jul 2013
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated with one of the oral diuretic therapy standards （include the patients who will be treated with one of the oral diuretic therapy standards from the beginning of the observation period）:
- Only 40 mg/day furosemide taken orally or other oral loop diuretics equivalent to 40 mg/day furosemide note 1)
- Combination treatment of oral loop diuretics and thiazide diuretics (no dosage limitation)
- Combination treatment of oral loop diuretics and aldosterone antagonists (no dosage limitation)
- Because of the existence of excess body fluid retention, the congestive heart failure patient has at least one of these symptoms (the lower extremity edema, pulmonary congestion note 2), or jugular vein engorgement).
- 20-85 years of age (inclusive) at the time of signing the informed consent document.
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- Gender: male or female.
- Inpatients or patient who would be hospitalized from one day before the observation period to the end of efficacy evaluation examination after the last dosing (from Day -4 to the end of efficacy evaluation examination after the last dosing).
- Patient who have signed the informed consent form.
Who cannot join
- Patients equipped with circulatory assistant device.
- Patients with any of following diseases, complications or symptoms:
- Suspected decreased blood volume
- Obstructive hypertrophic cardiomyopathy
- Severe aortic stenosis
- Hepatic coma
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- Patients with history of acute myocardial infarction within 30 days prior to screening.
- Patients with diagnosed active myocarditis or amyloid cardiomyopathy.
- Patients with the following diseases, complications or symptoms:
- Poorly controlled diabetes with a fasting glucose more than 220 mg/dL (or 12.21 mmol/L)
- Anuria
- Dysuria caused by urethral stricture, calculus or tumor
- Patients with the following medical history of:
- Sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to screening
- History of cerebrovascular accident within the past 30 days
- Past allergy or hypersensitive reactions to benzodiazepines (e.g. mozavaptan hydrochloride or benazepril hydrochloride)
- Obese patients whose body mass index (BMI = body weight (kg) / height (m)2 ) is more than 35.
- Patients with systolic pressure below 90 mmHg in supine position.
- Patients with any of the following abnormal laboratory test parameters:
- Total bilirubin > 2.5 times the upper limits of normal value
- Serum creatine > 2.5 times the upper limits of normal value
- Serum Na+ > 145 mmol/L (or higher than the upper limits of normal value)
- Serum K+ > 5.5 mmol/L
- Patients who unable to take medicine orally.
- Female patients who are pregnant, breast-feeding, at childbearing ages, or with pregnancy plan.
- Patients who participated in clinical trials of other medicine and took other study drugs within 30 days prior to sign the informed consent form.
- Patients who participated in the clinical trial of Tolvaptan and took Tolvaptan previously.
- Patients who have received approved Tolvaptan tablets (Trade name: Samsca) previously.
- Except for the above, patients who were unsuitable to participate in this trial in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Phase 3 Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Patients With Cardiac Edema Based on the Conventional Therapy
A randomized, double-blind, multicenter, placebo-controlled, parallel study to evaluate the efficacy and safety of Tolvaptan in the treatment of patients with cardiac edema (body fluid retention caused by congestive heart failure) based on the conventional therapy.
To evaluate the efficacy and safety of Tolvaptan 15 mg on congestive heart failure patients with body fluid retention after current diuretic treatment, after continuous treatment of 7 days' oral Tolvaptan 15mg or placebo.
Read the detailed description
- A randomized, double-blind, multicenter, placebo-controlled, parallel study
- Study population: The congestive heart failure patients with body fluid retention after received current diuretics therapy
- Number of patients: Patients will be randomly assigned to Tolvaptan and placebo group in 1:1 ratio, 120 patients in each group, 240 patients in total
- Group assignment method: Tolvaptan 15 mg group: conventional therapy + Tolvaptan 15 mg Placebo group: conventional therapy + placebo
- Administration and dosage of the study drug: Once daily, 1 tablet be taken orally after breakfast, for successive 7 days
- Study period:
- Screening period (4 days in minimum, 7 days in maximum), including:
Screening period: from the time the informed consent form is signed to Day -4 Observation period: 3 days before drug administration
- Treatment period: 7 days
- Follow up visits: Day 8 (efficacy evaluation day) and Day 7 (+3) after the last dosing
- Post treatment survey: Day 14 (+3) after the last dosing
- Conditions
- Cardiac Edema
- Being tested
- Tolvaptan, Placebo
- Medical subject headings
- Edema, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called Samsca
oral taken
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Frequency: once per day Duration: 7days Receives: Drug: Placebo |
| Tolvaptan | Experimental | Tolvaptan tablet Frequency: once per day Duration: 7days Receives: Drug: Tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight (change from baseline)
Measured: screening day, Day-3, Day-2, Day-1, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day(7+3)
Secondary outcomes (1)
Body weight (percent change from baseline)
Measured: screening day, Day-3, Day-2, Day-1, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day(7+3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac EdemaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhang Jian, Principal investigator, Fuwai Cardiovascular hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651156
- Sponsor's protocol ID
- 156-12-809-01
- Status last verified
- Dec 2013
- First submitted
- 24 Jul 2012
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Phase 3 Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Patients With Cardiac Edema Based on the Conventional Therapy
- ClinicalTrials.gov ID
- NCT01651156
- Acronym / sponsor ID
- 156-12-809-01
- Conditions
- Cardiac Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Jul 2012 (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.
A randomized, double-blind, multicenter, placebo-controlled, parallel study to evaluate the efficacy and safety of Tolvaptan in the treatment of patients with cardiac edema (body fluid retention caused by congestive heart failure) based on the conventional therapy.
To evaluate the efficacy and safety of Tolvaptan 15 mg on congestive heart failure patients with body fluid retention after current diuretic treatment, after continuous treatment of 7 days' oral Tolvaptan 15mg or placebo.
Detailed description
- A randomized, double-blind, multicenter, placebo-controlled, parallel study
- Study population: The congestive heart failure patients with body fluid retention after received current diuretics therapy
- Number of patients: Patients will be randomly assigned to Tolvaptan and placebo group in 1:1 ratio, 120 patients in each group, 240 patients in total
- Group assignment method: Tolvaptan 15 mg group: conventional therapy + Tolvaptan 15 mg Placebo group: conventional therapy + placebo
- Administration and dosage of the study drug: Once daily, 1 tablet be taken orally after breakfast, for successive 7 days
- Study period:
- Screening period (4 days in minimum, 7 days in maximum), including:
Screening period: from the time the informed consent form is signed to Day -4 Observation period: 3 days before drug administration
- Treatment period: 7 days
- Follow up visits: Day 8 (efficacy evaluation day) and Day 7 (+3) after the last dosing
- Post treatment survey: Day 14 (+3) after the last dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboFrequency: once per day Duration: 7days |
| Tolvaptan | Experimental | Drug: TolvaptanTolvaptan tablet Frequency: once per day Duration: 7days |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients treated with one of the oral diuretic therapy standards （include the patients who will be treated with one of the oral diuretic therapy standards from the beginning of the observation period）:
- Because of the existence of excess body fluid retention, the congestive heart failure patient has at least one of these symptoms (the lower extremity edema, pulmonary congestion note 2), or jugular vein engorgement).
- 20-85 years of age (inclusive) at the time of signing the informed consent document.
- Gender: male or female.
- Inpatients or patient who would be hospitalized from one day before the observation period to the end of efficacy evaluation examination after the last dosing (from Day -4 to the end of efficacy evaluation examination after the last dosing).
Key exclusion criteria (29 listed)
- Patients equipped with circulatory assistant device.
- Patients with any of following diseases, complications or symptoms:
- Patients with history of acute myocardial infarction within 30 days prior to screening.
- Patients with diagnosed active myocarditis or amyloid cardiomyopathy.
- Patients with the following diseases, complications or symptoms:
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 |
|---|---|---|
| TolvaptanAlso: Samscaoral taken | Drug | Tolvaptan |
| Placebo | Drug | placebo |
Primary outcome
body weight (change from baseline)
Time frame: screening day, Day-3, Day-2, Day-1, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day(7+3)
1 secondary outcome
Body weight (percent change from baseline)
Time frame: screening day, Day-3, Day-2, Day-1, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day(7+3)
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 Dec 2013.
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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.
Zhang Jian principal investigator
Fuwai Cardiovascular hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tolvaptan in people with Cardiac Edema, run by Otsuka Beijing Research Institute at 1 site in China.
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 9 inclusion and 29 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 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
body weight (change from baseline) (time frame: screening day, Day-3, Day-2, Day-1, Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day(7+3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2013.