A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients
- Conditions
- -I10 Essential (primary) hypertensionEssential (primary) hypertensionI10
- Registration Number
- PER-091-06
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1) Outpatients 18 years of age and older.
2) Male or female patients are eligible.
3) Patients with a diagnosis of hypertension.
4) Patients who are eligible and able to participate in the study, and who have given their consent after the purpose and nature of the research has been clearly explained to them.
1. Women who are pregnant or breastfeeding.
2. Women with reproductive potential, UNLESS they meet the definition of a postmenopausal woman OR who are using one or more of the acceptable methods of contraception.
3. Severe hypertension.
4. History or evidence of a secondary form of hypertension.
5. Known Keith-Wagener hypertensive retinopathy Grade III or IV.
6. Current or previous diagnosis of heart failure.
7. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
8. Serum potassium <3.5 mEq / L or ≥ 5.3 mEq / L, serum sodium less than the normal limit or dehydration.
9. Patients with type 1 or type 2 diabetes mellitus that are not well controlled.
10. Current pectoris angina that requires pharmacological therapy.
11. Second or third degree heart block without a pacemaker.
12. Atrial fibrillation or atrial flutter in Visit 1, or any symptomatic or life-threatening arrhythmia during the 12 months prior to Visit 1.
13. Clinically significant valvular heart disease.
14. Any medication, surgical or medical condition, that could significantly alter the absorption, distribution, metabolism, or excretion of investigational medications.
15. History of hypersensitivity to any of the medications or drugs that belong to the similar therapeutic class.
16. History of angioedema due to the use of a lECA or ARB.
17. History of malignancy in the last 5 years.
18. History of gouty arthritis.
19. History or evidence of drug or alcohol abuse in the last 12 months.
20. Any surgical or medical condition that could place the patient at greater risk due to his participation in the study, or that probably prevents the patient from meeting the requirements of the study or the completion of the study.
21. Patients who have been previously recruited during the active period of drug treatment from a clinical trial that has had the aliskiren / HCTZ combination treatment.
22. Use of other investigational drugs at the time of recruitment, or within 30 days or 5 half-lives of recruitment, whichever is longer.
23. History of noncompliance with medical regimens or lack of will to comply with the study protocol.
24. Any condition that could confuse the evaluation and interpretation of efficacy and / or safety data.
25. Persons directly involved in the execution of this protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The blood pressure should be determined in both arms and the arm in which the diastolic blood pressure was determined in the highest sitting position will be the arm used for all the readings.<br>Measure:Change from baseline (Visit 4) in the diastolic blood pressure in the average sitting position.<br>Timepoints:Week 8.<br>
- Secondary Outcome Measures
Name Time Method