Efficacy of Candesartan on Symptomatic Heart Failure in Treating Diabetic and Hypertensive Patients.

NCT00775840 | Completed Phase 3

• 4 other identifiers: BLO K0262007-003070-26D-CAN-546U1111-1113-9515
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 37

Brief Summary

The purpose of this study is to determine the effects of candesartan, once daily (QD), on the N-terminal pro-B-type Natriuretic Peptide laboratory marker in subjects with symptomatic heart failure with diastolic dysfunction.

Conditions

Heart Failure

Keywords

Cardiac Failure; Congestive Heart Failure; Drug Therapy; Hypertension; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The change from Baseline in N-terminal pro-B-type Natriuretic Peptide biomarker.

  Week 24 or Final Visit.

Secondary Outcomes (22)

• Mean change in N-terminal pro-B-type Natriuretic Peptide (log-transformed).

  Weeks 6 and 24 or Final Visit.

• Change from Baseline in Short Form-36 Health Survey score.

  Week 24 or Final Visit.

• Change from Baseline in Cystatin C.

  Week 24 or Final Visit.

• Change from Baseline in Adiponectin.

  Week 24 or Final Visit.

• Change from Baseline in Glycosylated Hemoglobin.

  Week 24 or Final Visit.

Study Arms (2)

Candesartan QD + Heart Failure Therapy

EXPERIMENTAL

(with angiotensin-converting enzyme-inhibitors/beta-blockers)

Drug: Candesartan

Placebo QD + Heart Failure Therapy

PLACEBO COMPARATOR

(with angiotensin-converting enzyme-inhibitors/beta-blockers)

Drug: Placebo

Interventions

Candesartan DRUG

Candesartan up to 32 mg, tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks.

Also known as: BLOPRESS®

Candesartan QD + Heart Failure Therapy

Placebo DRUG

Candesartan matching-placebo tablets, orally, once daily and ongoing angiotensin-converting enzyme inhibitor/beta-blocker therapy for up to 24 weeks.

Placebo QD + Heart Failure Therapy

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus type 2 - insulin dependent or orally treated or managed by diet for at least 3 Months.
• Normotension or controlled hypertension with sitting Systolic Blood Pressure less than 140 mmHg and/or sitting Diastolic Blood Pressure less than 90 mmHg.
• Regular sinus rhythm or atrial fibrillation with a medicamental-achieved rate control of less than 100 bpm as confirmed by electrocardiogram recordings.
• Echocardiographic evidence of a preserved Left Ventricular Ejection Fraction greater than or equal to 45% (assessed by the modified Simpson method), with further doppler-echocardiographic criteria for diastolic dysfunction grade I-IV.
• New York Heart Association classification of II or III in a stable condition since at least 3 months.
• Existing background heart failure therapy with an Angiotensin-Converting Enzyme Inhibitor alone or together with further preparations in a constant regimen since at least 1 month, in case of beta-blockers since at least 3 months.
• N-terminal pro-B-type Natriuretic Peptide greater than or equal to 250 pg/ml measured at screening visit or collected from a dated previous laboratory document not older than 3 months.
• No previous therapy with Angiotensin-Receptor Blockers during the last 4 weeks prior to the study.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

You may not qualify if:

• Impaired renal function (serum creatinine greater than 2.2 mg/dl or greater than 194 μmol/l).
• Known bilateral renal artery stenosis or interventional treatment for renal artery stenosis in the last year.
• State after kidney transplantation.
• Serum potassium greater than 5.5 mmol/l or glycosylated hemoglobin greater than 9.5 %.
• Cor pulmonale or primary pulmonary disease with dyspnea at rest.
• Known disposition to episodes of symptomatic hypotension or sitting Systolic Blood Pressure less than 95 mmHg at baseline.
• Acute coronary syndrome or any form of unstable chronic Coronary Artery Disease where the indication of a coronary intervention is either planned in short or medium term or can not be clearly excluded for the period of the study.
• Any history of: myocardial infarction, previous Percutaneous Transluminal Coronary Angioplasty with revascularization, stent implantation, Coronary Artery Bypass Graft or open heart surgery.
• Tachycardia at rest greater than 100 bpm as confirmed by electrocardiogram recordings.
• Known clinically relevant rhythm disorders (e.g., tachyarrhythmias, salves of supraventricular or ventricular extrasystoles or atrial fibrillation without ventricular rate control) or symptoms suggesting a significant rhythm disorder (e.g., recurrent syncopes).
• Primary valvular diseases and/or restrictive or obstructive cardiomyopathy.
• Existing ventricular assist devices.
• Relevant liver diseases (cholestasis or alanine aminotransferase/aspartate aminotransferase greater than 2 times the upper limit of normal or gamma- glutamyltransferase greater than 3 times the upper limit of normal).
• History of primary hyperaldosteronism, of cancer in the last 5 years or of another wasting disease with life expectancy of less than 2 years.
• Known hypersensitivity to Candesartan Cilexetil.

Sponsors & Collaborators

• Takeda: lead

Study Sites (37)

Unknown Facility

Bad Friedrichshall, Baden-Wurttemberg, Germany

Location

Unknown Facility

Heidelberg, Baden-Wurttemberg, Germany

Location

Unknown Facility

Ludwigsburg, Baden-Wurttemberg, Germany

Location

Unknown Facility

Bad Homburg, Hesse, Germany

Location

Unknown Facility

Bad Nauheim, Hesse, Germany

Location

Unknown Facility

Darmstadt, Hesse, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, Germany

Location

Unknown Facility

Giessen, Hesse, Germany

Location

Unknown Facility

Kassel, Hesse, Germany

Location

Unknown Facility

Limburg an der Lahn, Hesse, Germany

Location

Unknown Facility

Melsungen, Hesse, Germany

Location

Unknown Facility

Mühlheim am Main, Hesse, Germany

Location

Unknown Facility

Wiesbaden, Hesse, Germany

Location

Unknown Facility

Nienburg, Lower Saxony, Germany

Location

Unknown Facility

Northeim, Lower Saxony, Germany

Location

Unknown Facility

Weyhe, Lower Saxony, Germany

Location

Unknown Facility

Essen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Gelsenkirchen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Gladbeck, North Rhine-Westphalia, Germany

Location

Unknown Facility

Langenfeld, North Rhine-Westphalia, Germany

Location

Unknown Facility

Paderborn, North Rhine-Westphalia, Germany

Location

Unknown Facility

Siegen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Bad Kreuznach, Rhineland-Palatinate, Germany

Location

Unknown Facility

Neukirchen, Saarland, Germany

Location

Unknown Facility

Dresden, Saxony, Germany

Location

Unknown Facility

Hartmannsdorf, Saxony, Germany

Location

Unknown Facility

Leipzig, Saxony, Germany

Location

Unknown Facility

Leisnig, Saxony, Germany

Location

Unknown Facility

Machem, Saxony, Germany

Location

Unknown Facility

Markkleeberg, Saxony, Germany

Location

Unknown Facility

Riesa, Saxony, Germany

Location

Unknown Facility

Wermsdorf, Saxony, Germany

Location

Unknown Facility

Coswig, Saxony-Anhalt, Germany

Location

Unknown Facility

Berlin, State of Berlin, Germany

Location

Unknown Facility

Erfurt, Thuringia, Germany

Location

Unknown Facility

Jena, Thuringia, Germany

Location

Unknown Facility

Nordhausen, Thuringia, Germany

Location

MeSH Terms

Conditions

Heart Failure; Hypertension; Diabetes Mellitus

Interventions

candesartan; candesartan cilexetil

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Director

  Takeda Pharma Gmbh, Aachen (Germany)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 22, 2010

Record last verified: 2010-06

Locations

DE (37)