Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219180
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011

September 12, 2005
November 7, 2011
June 2005
September 2006   (final data collection date for primary outcome measure)
Change from baseline in diastolic blood pressure after week 8
Not Provided
Complete list of historical versions of study NCT00219180 on ClinicalTrials.gov Archive Site
  • Change from baseline in systolic blood pressure after week 8
  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 and 8 weeks
  • Blood pressure control target of < 140/90 mmHg after 4 and 8 weeks
  • Evaluate 24-hour ambulatory blood pressure monitoring in a subset of patients
Not Provided
Not Provided
Not Provided
 
Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure
An 8-week Multi-center, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren (150 mg and 300 mg) Administered Alone and in Combination With Valsartan (160 mg and 320 mg) in Patients With Hypertension

To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: aliskiren
Not Provided
Oparil S, Yarows SA, Patel S, Fang H, Zhang J, Satlin A. Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial. Lancet. 2007 Jul 21;370(9583):221-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1797
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Patients with essential hypertension
  • 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
Germany,   United States
 
NCT00219180
CSPP100A2327
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2011

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