An eight-week, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / HCTZ (150/25 mg and 300/25 mg) in comparison with HCTZ 25 mg in patients with essential hypertension not adequately responsive to HCTZ 25 mg monotherapy
- Conditions
- Hypertension
- Registration Number
- EUCTR2005-004580-40-HU
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 726
(For full list, please see protocol)
- Outpatients 18 years of age and older.
- Male or female patients are eligible.
- 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 = 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 > 85 mmHg and < 110 mmHg at Visit 2.
- All patients must have a msDBP = 90 mmHg and < 110 mmHg at Visit 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
(For full list, please see protocol)
- Pregnant or nursing (lactating) women,
- Women of child-bearing potential (WOCBP)
- Severe hypertension (msDBP = 110 mmHg and/or msSBP = 180 mmHg).
- History or evidence of a secondary form of hypertension.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- Previous or current diagnosis of heart failure.
- History of hypertensive encephalopathy or cerebrovascular accident, transient
ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or
any percutaneous coronary intervention (PCI).
- 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.
- 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.
- Current angina pectoris requiring pharmacological therapy.
- Second or third degree heart block without a pacemaker.
- Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any
symptomatic arrhythmia during the 12 months prior to Visit 1.
- Clinically significant valvular heart disease.
- Any medication, surgical or medical condition which might significantly alter the
absorption, distribution, metabolism, or excretion of study drugs including, but not
limited to, any of the following:
- History of major gastrointestinal tract surgery such as gastrectomy,
gastroenterostomy, or bowel resection.
- History of active inflammatory bowel disease during the 12 months prior to
Visit 1.
- Currently active gastritis, duodenal or gastric ulcers, or history of
gastrointestinal bleeding during the 3 months prior to Visit 1.
- Evidence of hepatic disease as determined by any one of the following: ALT or
AST values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy,
a history of esophageal varices, or a history of portocaval shunt.
- Evidence of renal impairment as determined by any one of the following:
serum creatinine > 1.5 x ULN at Visit 1, a history of dialysis, or a history of
nephrotic syndrome.
- Current treatment with cholestyramine and colestipol resins.
- History of hypersensitivity to any of the study drugs or to drugs belonging to the
similar therapeutic class (ARB’s, ACE-I’s, thiazide diuretics, or other sulfonamide
derived drugs) as the study drugs.
- History of angioedema due to usage of an ACE-I or ARB.
- History of malignancy of any organ system, treated or untreated, within the past 5
years whether or not there is evidence of local recurrence or metastases, with the
exception of localized basal cell carcinoma of the skin.
- History of gouty arthritis
- History or evidence of drug or alcohol abuse within the last 12 months.
- Any surgical or medical condition, which in the opinion of the investigator, may
place the patient at higher risk from his/her participation in the study, or is likely to
prevent the patient from complying with the requirements of the study or
completing the study.
- Patients who previously participated in a clinical trial that contained the trea
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method