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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

Page last updated: October 04, 2010

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