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Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219037
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: June 2006

September 12, 2005
November 7, 2011
June 2004
October 2005   (final data collection date for primary outcome measure)
Adverse events, laboratory abnormalities, serious adverse events
Not Provided
Complete list of historical versions of study NCT00219037 on ClinicalTrials.gov Archive Site
  • Change from baseline in mean sitting diastolic blood pressure after 12 months
  • Change from baseline in mean sitting systolic blood pressure after 12 months
  • Change from baseline in standing systolic blood and diastolic pressure after 12 months
  • Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline
  • Blood pressure less than 140/90 mmHg
Not Provided
Not Provided
Not Provided
 
Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension
A 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension.

Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Hypertension
Drug: aliskiren
Not Provided
Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.2165/11590280-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1955
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Patients with essential hypertension.
  2. Patients who are eligible and able to participate in the study.

Exclusion Criteria

  1. Severe hypertension.
  2. History or evidence of a secondary form of hypertension.
  3. 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
 
NCT00219037
CSPP100A2302
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