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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 September 2012 |
Main ID: |
EUCTR2008-003199-23-IT |
Date of registration:
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16/10/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An 8 week, double-blind, randomized, parallel group, active-controlled study to evaluate the efficacy and safety of the combination of Aliskiren /Amlodipine / HCTZ in patients with moderate to severe hypertension - ND
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Scientific title:
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An 8 week, double-blind, randomized, parallel group, active-controlled study to evaluate the efficacy and safety of the combination of Aliskiren /Amlodipine / HCTZ in patients with moderate to severe hypertension - ND |
Date of first enrolment:
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05/03/2009 |
Target sample size:
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1160 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003199-23 |
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: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Denmark
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Germany
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Italy
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Latvia
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Lithuania
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Sweden
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion Criteria 1. Outpatients 18 years of age or older 2. Male or female patients are eligible. 3. msDBP & msSBP Requirements: 3A: o Diagnosis of moderate to severe hypertension (msSBP ≥ 160 mmHg and < 200 mmHg, and/or msDBP ≥ 100 mmHg and < 120 mmHg) at Visits 4, 5 or 6 (Qualifying BP visit) o In addition, at the visit immediately prior to the above qualifying visit, patients must also have msSBP ≥ 145 mmHg and < 200 mmHg and msDBP ≥ 95 mmHg and < 120 mmHg) at Visits 3, 4 or 5 o Patients must meet the above two sets of requirements at subsequent adjacent visits, i.e., either Visits 3 and 4, Visits 4 and 5, or Visits 5 and 6 OR 3B: o msSBP ≥ 180 mmHg and < 200 mmHg with msDBP ≥ 95 mmHg and < 120 mmHg, or msDBP ≥ 110 mmHg and < 120 mmHg with msSBP ≥ 150 mmHg and < 200 mmHg after at least one week of treatment with placebo (Visit 3 and on) 4. For patients requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase (placebo period) of the study. 5. Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Exclusion Criteria: 1. Inability to discontinue all prior antihypertensive medications at Visit 2 (start of placebo) or complete the taper within 4 weeks after Visit 1. 2. Patients with an msSBP ≥ 200 mmHg or msDBP ≥ 120 mmHg at any time during the placebo run-in period must be discontinued from the study. 3. Patients on four or more antihypertensive drugs at Visit 1. 4. Pregnant or nursing (lactating) women, where pregnancy is defined as a state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 10 mIU/ml). 5. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception such as surgical sterilization (e.g., bilateral tubal ligation) or hormonal contraception (implantable, patch, oral), or double-barrier methods (if accepted by the local Health Authority and Ethics Committee) Reliable contraception should be maintained throughout the study and for 7 days after study medication discontinuation.PLS SEE PROTOC.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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moderate to severe hypertension MedDRA version: 9.1
Level: LLT
Classification code 10015488
Term: Essential hypertension
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Intervention(s)
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Product Name: RASILEZ Product Code: SPP100A Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ALISKIREN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: RASILEZ Product Code: SPP100A Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ALISKIREN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: NORVASC Pharmaceutical Form: Capsule, hard INN or Proposed INN: Amlodipine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Trade Name: NORVASC Pharmaceutical Form: Capsule, hard INN or Proposed INN: Amlodipine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Trade Name: ESIDREX Pharmaceutical Form: Capsule, hard INN or Proposed INN: Hydrochlorothiazide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Trade Name: ESIDREX Pharmaceutical Form: Capsule, hard INN or Proposed INN: Hydrochlorothiazide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The primary objective of the study is to demonstrate that a once daily dosing regimen of the triple combination of aliskiren/amlodipine/HCTZ is superior to the double combinations of aliskiren/amlodipine, aliskiren/HCTZ and amlodipine/HCTZ in lowering mean sitting systolic blood pressure (msSBP) in patients with moderate to severe hypertension.
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Secondary Objective: To demonstrate that a once daily dosing regimen of the triple combination of aliskiren/amlodipine/HCTZ is superior to the double combinations of aliskiren/amlodipine, aliskiren/HCTZ and amlodipine/HCTZ in lowering mean sitting diastolic blood pressure (msDBP) in patients with moderate to severe hypertension. To evaluate the blood pressure control rates (msSBP/msDBP < 140/90 mmHg) of the triple combination of aliskiren/HCTZ/amlodipine in comparison to the double combinations of aliskiren/HCTZ, aliskiren/amlodipine and HCTZ/amlodipine in patients with moderate to severe hypertension. To evaluate the diastolic blood pressure responder rates (msDBP < 90 mmHg and/or ≥ 10 mmHg reduction from baseline) of the triple combination of aliskiren/HCTZ/amlodipine in comparison to the double combinations of aliskiren/HCTZ, aliskiren/amlodipine and HCTZ/amlodipine in patients with moderate to severe hypertension. PLS SEE PROTOC.
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Primary end point(s): The primary efficacy variable is change from baseline in msSBP. msSBP is the average of available readings of sitting systolic blood pressure for a given visit. The primary analysis time point will be the Week 8 endpoint. For each patient, the last post-baseline measurement during the double-blind treatment period will be carried forward to Week 8 as the Week 8 endpoint measurement.
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Secondary ID(s)
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CSAH100A2302
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2008-003199-23-DK
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Source(s) of Monetary Support
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Results
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Results available:
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