Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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11 August 2014 |
Main ID: |
EUCTR2013-001643-30-SK |
Date of registration:
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03/07/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An 8-week study to evaluate the efficacy (blood pressure lowering effect) and safety of LCZ696 given alone and in combination with amlodipine
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Scientific title:
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An 8-week randomized, double-blind, placebo-controlled factorial study to evaluate the efficacy and safety of LCZ696 alone and in combination with amlodipine in patients with essential hypertension |
Date of first enrolment:
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09/10/2013 |
Target sample size:
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1386 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001643-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 9
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Phase:
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Countries of recruitment
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Argentina
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Brazil
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Colombia
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Dominican Republic
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Ecuador
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Guatemala
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Mexico
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Panama
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Peru
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Philippines
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Russian Federation
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Slovakia
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South Africa
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Spain
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Thailand
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Vietnam
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Contacts
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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+4161324 1111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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+4161324 1111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Male or female outpatients.
2.Patients with mild-to- moderate hypertension, untreated or currently taking antihypertensive therapy.
3.Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1)
must have an msSBP =150 mmHg and<180 mmHg at the randomization visit and msSBP =140 mmHg <180 mmHg at the preceding visit.
4.Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP =150.mmHg and <180 mmHg at both the randomization visit and the preceding visit.
5.Patients must have an absolute difference of =15 mmHg in msSBP between the randomization visit and the preceding visit.
6.Ability to communicate and comply with all study requirements and demonstrate good medication compliance (= 80% compliance rate) during the treatment run-in period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 286
Exclusion criteria: 1.Severe hypertension (msDBP =110 mmHg and/or msSBP = 180 mmHg).
2.History of angioedema, drug- related or otherwise.
3.History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing’s disease, pheochromocytoma, polycystic kidney disease, and drug- induced hypertension.
4.Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
5.History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
6.Pregnant or lactating women.
7.Women of child-bearing potential not using highly effective methods of contraception.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Essential hypertension MedDRA version: 16.0
Level: PT
Classification code 10015488
Term: Essential hypertension
System Organ Class: 10047065 - Vascular disorders
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Intervention(s)
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Product Code: LCZ696 Pharmaceutical Form: Tablet INN or Proposed INN: Not established CAS Number: 936623-90-4 Current Sponsor code: LCZ696 Other descriptive name: LCZ696 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: Amlodipin Hexal 5 mg Tabletten Product Name: amlodipine besylate Pharmaceutical Form: Tablet INN or Proposed INN: Amlodipine Other descriptive name: AMLODIPINE BESILATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in combination with amlodipine in patients with essential hypertension.
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Secondary Objective: 1.evaluate efficacy of LCZ696 compared to placebo, measured by change in mean sitting BP (msDBP) from BS after 8 weeks treatment in patients with essential HT. 2.evaluate efficacy of combination of LCZ696 and amlodipine compared to monotherapy, measured by change msDBP from BS after 8 weeks treatment in pts with essential HT. 3.evaluate office and ambulatory pulse pressure for all trtment groups after 8 wks trtment. 4.evaluate efficacy of LCZ696 compared to placebo, measured by change in mean 24-hour ambulatory (maSBP), mean 24-hour ambulatory (maDBP), daytime and nighttime maSBP/maDBP, trough/peak ratios of maSBP and maDBP from baseline after 8 wks trtment in a subset of patients with essential HT. 5.evaluate efficacy of combination of LCZ696 and amlodipine compared to monotherapy, measured by change in mean 24-hour ambulatory maSBP), mean 24-hour ambulatory (maDBP), daytime and nighttime maSBP/maDBP from baseline after 8 weeks treatment in a subset of patients with essential HT.
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Primary end point(s): 1.Change from baseline in mean sitting systolic blood pressure (msSBP) of LCZ696 monotherapy compared to placebo. 2.Change from baseline in mean sitting systolic blood pressure (msSBP) of the combination of LCZ696 and amlodipine compared to LCZ696 and amlodipine alone.
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Timepoint(s) of evaluation of this end point: 1.at baseline, 8 weeks 2.at baseline, 8 weeks
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. from baseline after 8 weeks of treatment.
2. from baseline after 8 weeks of treatment.
3. after 8 weeks of treatment.
4. from baseline after 8 weeks of treatment.
5. from baseline after 8 weeks of treatment.
6. after 8 weeks of treatment.
7. after 8 weeks of treatment.
8. after 8 weeks of treatment.
9. after 8 weeks of treatment.
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Secondary end point(s): 1. To evaluate the efficacy of LCZ696 200mg and 400mg compared to placebo, as measured by change in mean sitting diastolic BP (msDBP) from baseline after 8 weeks of treatment in patients with essential hypertension.
2. To evaluate the efficacy of combination of LCZ696 and amlodipine (200/5mg, 200/10mg, 400/5mg and 400/10 mg) compared to monotherapy, as measured by change in msDBP from baseline after 8 weeks of treatment in patients with essential hypertension.
3. To evaluate office and ambulatory pulse pressure for all treatment groups after 8 weeks of treatment.
4. To evaluate the efficacy of LCZ696 200mg and 400mg compared to placebo, as measured by change in mean 24-hour ambulatory SBP (maSBP), mean 24-hour ambulatory DBP (maDBP), daytime and nighttime maSBP/maDBP, trough/peak ratios of maSBP and maDBP from baseline after 8 weeks of treatment in a subset of patients with essential hypertension.
5. To evaluate the efficacy of combination of LCZ696 and amlodipine (200/5mg, 200/10mg, 400/5mg and 400/10 mg) compared to monotherapy, as measured by change in mean 24-hour ambulatory SBP (maSBP), mean 24-hour ambulatory DBP (maDBP), daytime and nighttime maSBP/maDBP from baseline after 8 weeks of treatment in a subset of patients with essential hypertension.
6. To assess the proportion of patients achieving blood pressure control (msSBP<140 mmHg and msDBP <90 mmHg) for all treatment groups after 8 weeks of treatment.
7. To assess the proportion of patients achieving a successful response in msSBP (< 140 mmHg or a reduction = 20 mmHg from baseline) for all treatment groups after 8 weeks of treatment.
8. To assess the proportion of patients achieving a successful response (msDBP < 90 mmHg or a reduction = 10 mmHg from baseline) for all treatment groups after 8 weeks of treatment.
9. To evaluate the safety of LCZ696 and its combination with amlodipine (200/5mg, 200/10mg, 400/5mg and 400/10 mg) in patients with essential hypertension.
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Secondary ID(s)
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CLCZ696A2320
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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