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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002673-38 | EudraCT Number |
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In view of outcome of RELAX-AHF-2 trial, the entire RLX030A project was decided to be terminated.
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This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serelaxin followed by Placebo | Experimental | On Day 1 of treatment period 1, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. |
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| Placebo followed by Serelaxin | Experimental | On Day 1 of treatment period 1, matching placebo will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen The routine exercise assessment will commence at minute 120. In treatment period 2, on day 15 ± 1-day washout, Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serelaxin | Drug | Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo | This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. | Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours | This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. | 4 and 5 hours after exercise testing session |
| Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo |
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Key Inclusion Criteria:
Male or female ≥ 18 years of age, with body weight ≤ 160 Kg
Diagnosis of stable CHF:
Left ventricular ejection fraction < 45%, obtained within the last 3 months prior to screening.
NT-proBNP > 300 ng/L in sinus rhythm or > 900 ng/L if not in sinus rhythm (determined locally).
Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.
Systolic BP ≥ 125 mmHg at randomization
Renal function defined as an eGFR of ≥ 25 mL/min/1.73 m^2 at screening (sMDRD formula).
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany | ||
| Novartis Investigative Site |
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There were total 11 centers from 3 countries. (Germany-6, Switzerland-1, and the United Kingdom-4).
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| ID | Title | Description |
|---|---|---|
| FG000 | Serelaxin-Placebo | Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2. Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion. |
| FG001 | Placebo-Serelaxin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Matching placebo i.v infusion |
|
This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. |
| Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1) |
| Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo | This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. | Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1) |
| Berlin |
| 10117 |
| Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | München | 80636 | Germany |
| Novartis Investigative Site | München | 81675 | Germany |
| Novartis Investigative Site | Basel | 4031 | Switzerland |
| Novartis Investigative Site | Hull | HU16 5JQ | United Kingdom |
| Novartis Investigative Site | London | SW 6NP | United Kingdom |
| Novartis Investigative Site | Tyne and Wear | NE2 4HH | United Kingdom |
Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2. Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion. |
| Completed Treatment Period 1 |
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| Completed Treatment Period 2 |
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| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) consisted of all randomized patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Serelaxin-Placebo | Subjects received serelaxin in Treatment Period 1 and placebo in Treatment Period 2. Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion. |
| BG001 | Placebo-Serelaxin | Subjects received placebo in Treatment Period 1 and serelaxin in Treatment Period 2. Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. Matching placebo was administered as an i.v infusion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Weight (kg) | Mean | Standard Deviation | kilogram (kg) |
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| Childbearing status | Number of post-menopausal participants. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo | This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. | The primary analysis of mixed model repeated measures was not performed because the validation of the primary endpoint variable hs-cTnI assay (Singulex Erenna®) was not completed because of the early termination of the study and, therefore, hs-cTnI was not analyzed. | Posted | Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1) |
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| Secondary | Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours | This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. | The objective was not analyzed because the validation of the hs-cTnI Singulex Erenna® assay was not completed because of the early termination of the study. | Posted | 4 and 5 hours after exercise testing session |
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| Secondary | Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo | This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. | The full analysis set (FAS) consisted of all randomized patients. | Posted | Mean | Standard Deviation | pg/mL | Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1) |
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| Secondary | Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo | This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. | The full analysis set (FAS) consisted of all randomized patients. Patients were analyzed according to the treatment they had been assigned to at randomization. | Posted | Mean | Standard Deviation | ng/mL | Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1) |
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Adverse Events are monitored from on or after the time of first administration of study treatment up to 30 days after the last administration were included.
The safety set consisted of all patients who received any amount of study treatment and had at least one post-baseline safety assessment. 22 participants were included in the safety set because 4 randomized patients did not receive study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Serelaxin | Participants receiving serelaxin in Treatment Period 1 and in Treatment Period 2. Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout. Serelaxin was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. | 0 | 20 | 0 | 20 | 7 | 20 |
| EG001 | Placebo | Participants receiving placebo in Treatment Period 1 and in Treatment Period 2. Each participant received each of the treatments in randomized order in 2 treatment periods separated by a 15 +/- 1-day washout. Placebo was administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen. | 0 | 20 | 1 | 20 | 6 | 20 |
| EG002 | Total | Total | 0 | 22 | 1 | 22 | 12 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Iron deficiency | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
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The study was terminated early by Novartis, 19-Apr-2017. Because of the early termination of the study, the validation of the hs-cTnI assay was not completed and the primary efficacy endpoint was not analyzed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until publication of the pooled data (i.e.,data from all sites)in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| C577649 | serelaxin protein, human |
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