Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).
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ClinicalTrials.gov Identifier: NCT00159627 |
Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : January 29, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure, Congestive | Drug: KW-3902IV | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of the Effects of KW-3902 on Diuresis in Patients With Congestive Heart Failure (CHF) Refractory to High Dose Diuretic Therapy |
Study Start Date : | August 2004 |

- Change in urine volume from baseline

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of CHF for greater than 3 months,
- Receiving oral/IV diuretic therapy
- Hospitalized for therapy for HF and edema that has not responded to diuretic therapy.
- Signs and symptoms of ongoing volume overload
Exclusion Criteria:
- Myocardial infarction in past 14 days
- Clinical evidence of acute coronary syndrome causing worsening of HF,
- Pregnant or breast-feeding,
- Severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
- Automated implanted cardiac defibrillator (AICD) or synchronization device implanted within the preceding 7 days,
- Require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
- Deterioration due to an acute or superimposed condition requiring therapy other than diuretics
- Symptomatic ventricular tachycardia,
- Severe concomitant primary hepatic disease,
- Severe pulmonary disease,
- Any other concomitant life-threatening disease,
- CVA in the preceding 6 months,
- Hypotension,
- Participated in another clinical trial within 30 days,
- Acute contrast nephropathy,
- Admitted for heart transplant surgery or have had a heart transplant.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159627
United States, California | |
Stanford, California, United States | |
United States, District of Columbia | |
Washington, District of Columbia, United States | |
United States, Florida | |
Sarasota, Florida, United States | |
United States, Maryland | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Ayer, Massachusetts, United States | |
Boston, Massachusetts, United States | |
United States, New Jersey | |
Newark, New Jersey, United States | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States | |
United States, South Carolina | |
Charleston, South Carolina, United States | |
United States, Tennessee | |
Tullahoma, Tennessee, United States |
ClinicalTrials.gov Identifier: | NCT00159627 |
Other Study ID Numbers: |
CKI-202 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | January 29, 2008 |
Last Verified: | January 2008 |
heart failure, congestive diuretic |
Heart Failure Heart Diseases Cardiovascular Diseases Rolofylline |
Diuretics Natriuretic Agents Physiological Effects of Drugs |