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A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219089
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: June 2006

September 12, 2005
November 7, 2011
November 2004
August 2005   (final data collection date for primary outcome measure)
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Not Provided
Complete list of historical versions of study NCT00219089 on ClinicalTrials.gov Archive Site
  • Change from baseline to week 4 endpoint in mean sitting diastolic blood pressure
  • Change from baseline to week 8 endpoint in mean sitting systolic blood pressure
  • Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks
Not Provided
Not Provided
Not Provided
 
A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.
An Eight-week, Randomized, Double-blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus

To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension, Diabetes Mellitus
Drug: aliskiren
Not Provided
Uresin Y, Taylor AA, Kilo C, Tschöpe D, Santonastaso M, Ibram G, Fang H, Satlin A. Efficacy and safety of the direct renin inhibitor aliskiren and ramipril alone or in combination in patients with diabetes and hypertension. J Renin Angiotensin Aldosterone Syst. 2007 Dec;8(4):190-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
839
August 2005
August 2005   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Patients with essential hypertension
  • Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
  • Patients who are eligible and able to participate in the study

Exclusion Criteria

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00219089
CSPP100A2307
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP