Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: Aliskiren (Drug); Ramipril (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis, Phone: + 41 61 324 1111
Summary
This prospective multicenter, double blind study will evaluate the efficacy and safety of
aliskiren versus ramipril in patients with moderate systolic essential hypertension.
Clinical Details
Official title: Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in mean sitting systolic blood pressure (msSBP)
Secondary outcome: Change mean sitting diastolic blood pressure (msDBP)percentage of patients with controlled blood pressure (i.e. BP< 140/90 mmHg) change in msSBP and msDBP from last active dose taken to after a one-day missed-dose Measure systolic and diastolic morning surge (ABPM evaluation)after 8 weeks of treatment Safety assessment of adverse events, physical examination, laboratory assessments, patient discontinuation rates
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Outpatients > 18 years
- Male or female patients. Female patients must have been either post-menopausal for
one year, surgically sterile, or using effective contraceptive methods
- Patients with essential hypertension, previously treated with an antihypertensive
monotherapy, either uncontrolled or intolerant.
- BP thresholds at visit 1:
- For patients previously treated and uncontrolled: 140≤ office SBP<180 mmHg
- For patients previously treated, controlled but intolerant: office SBP≥130 mmHg
- BP thresholds at visit 2 (for all patients):
- 160≤office SBP<180 mmHg AND
- 155≤home SBP<175 mmHg (3-day period of home blood pressure monitoring)
Exclusion Criteria:
- Women of child-bearing potential not using any effective methods of contraception
- Severe HTN (office BP ≥ 180/110 mmHg)
- Impossibility to stop abruptly previous antihypertensive treatments at visit 1
- Patients previously untreated or patients treated with two or three antihypertensive
medications
- History or evidence of a secondary form of hypertension
- History of hypersensitivity to ACEi or renin inhibitors
- History of heart failure, stroke or coronary heart disease
- Serum potassium ≥ 5. 2 mmol/l
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis, Phone: + 41 61 324 1111
Investigative Site, Aire-sur-adour, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Angers, France; Recruiting
Novartis, Phone: 41 61 324 1111
Investigative Site, Becon-les-granits, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Chateau-gontier, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Cherbourg, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Château-gontier, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Laval, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Lury-sur-arnon, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Luynes, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Mont-de-marsan, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Mortagne-sur-sevre, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Mourmelon-le-petit, France; Recruiting
Novartis, Phone: 41 61 324 1111
Investigative Site, Orchiles, France; Recruiting
Novartis, Phone: 41 61 324 1111
Investigative Site, Paris, France; Recruiting
Novartis, Phone: 41 61 324 1111
Investigative Sites, Saint-avertin, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Saint-orens-de-gameville, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Saint-seurin-de-cursac, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Scorbe-clairvaux, France; Recruiting
Novartis, Phone: 41-61-324-1111
Invesitagtive Site, Seysses, France; Recruiting
Novartis, Phone: 41-61-324-1111
Investigative Site, Toulon, France; Recruiting
Novartis, Phone: 41 61 324 1111
Investigative Site, Toulouse, France; Recruiting
Novartis, Phone: 41-61-324-1111
Additional Information
Starting date: November 2009
Last updated: August 25, 2010
|
