An eight-week, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in comparison with aliskiren 300 mg in patients with essential hypertension not adequately responsive to aliskiren 300 mg monotherapy - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-004579-39-IT
• Date of registration: 09/05/2007
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: An eight-week, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in comparison with aliskiren 300 mg in patients with essential hypertension not adequately responsive to aliskiren 300 mg monotherapy - ND
• Scientific title: An eight-week, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in comparison with aliskiren 300 mg in patients with essential hypertension not adequately responsive to aliskiren 300 mg monotherapy - ND
• Date of first enrolment: 21/07/2006
• Target sample size: 792
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004579-39
• Study type: Interventional clinical trial of medicinal product
• Study design: 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: no Other: no

Countries of recruitment

Germany, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Outpatients 18 years of age and older. 2. Male or female patients are eligible. 3. Patients with a diagnosis of hypertension: ? Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP sup/uguale a 95 mmHg and < 110 mmHg at Visit 1. ? All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP sup/uguale a 85 mmHg and < 110 mmHg at Visit 2. ? All patients must have a msDBP sup/uguale a 90 mmHg and < 110 mmHg at Visit 4.
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:
1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>= 5 mIU/ml). 2. 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/m 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) and hormonal contraception (implantable, patch, oral). Reliable contraception should be maintained throughout the study and for 7 days after medication discontinuation. 3. Severe hypertension (msDBP >= 110 mmHg and/or msSBP >= 180 mmHg). 4. History or evidence of a secondary form of hypertension. 5. Known Keith-Wagener grade III or IV hypertensive retinopathy. 6. Previous or current diagnosis of heart failure. 7. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 8. Serum potassium < 3.5 mEq/L (mmol/L) or >= 5.3 mEq/L (mmol/L), serum sodium less than the lower limit of normal or dehydration. 9. Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled based on the investigator?s clinical judgment. Patients with diabetes mellitus enrolled in this study should be well controlled. It is recommended that patients currently being treated for diabetes mellitus be on a stable dose of oral antidiabetic medication for at least 4 weeks prior to Visit 1. 10. Current angina pectoris requiring pharmacological therapy. 11. Second or third degree heart block without a pacemaker. 12. Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1. 13. Clinically significant valvular heart disease.(please see protocol)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

essential hypertension
MedDRA version: 6.1 Level: PT Classification code 10015488

Intervention(s)

Product Name: aliskiren
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: SPH100
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

Trade Name: ESIDREX*20CPR 25MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydrochlorothiazide
CAS Number: 58-93-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: ESIDREX*20CPR 25MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydrochlorothiazide
CAS Number: 58-93-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: aliskiren
Product Code: SPP100
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: SPH100
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

Primary Outcome(s)

Main Objective: Demonstrate the efficacy of the combination therapy of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of aliskiren 300 mg by testing the hypothesis of superior reduction in mean sitting diastolic blood pressure (msDBP) from baseline to end of study when compared to aliskiren 300 mg monotherapy

Primary end point(s): The primary efficacy variable is change from baseline (Visit 4) in mean sitting diastolic blood

pressure. For each patient, the last post-baseline measurement during the double-blind period will be carried forward to Week 8 as the endpoint measurement for the variable to be

analyzed. The primary analysis timepoint will be the endpoint.

Secondary Objective: Evaluate the efficacy of the combination therapy of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of aliskiren 300 mg by testing the hypothesis of superior reduction in mean sitting systolic blood pressure (msSBP) from baseline to end of study when compared to aliskiren 300 mg monotherapy 2. Evaluate the safety and tolerability of the combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) compared with aliskiren 300 mg monotherapy in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of aliskiren 300 mg 3. Evaluate the proportion of patients achieving a blood pressure control target of < 140 / 90 mmHg at the end of study for all treatment arms.

Secondary ID(s)

2005-004579-39-DE

CSPP100A2332