A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00219193
• Collaborator: (none)
• Enrollment: 641
• Locations: 2
• Duration (Months): 15
• Patients Per Site: 320.5
• Patients Per Site Per Month: 21.3

Study Details

Study Description

Brief Summary

To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: aliskiren	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 641 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: An Eight Week, Multicenter Study to Evaluate Efficacy and Safety of the Triple Combo of Aliskiren /Valsartan/HCTZ (300/320/25 mg), Compared to the Double Combos of Aliskiren/HCTZ (300/25 mg) or Valsartan/HCTZ (320/25 mg) in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jan 1, 2007

Outcome Measures

Primary Outcome Measures

1. Change from baseline in diastolic blood pressure after 8 weeks []

Secondary Outcome Measures

1. Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks []

2. Change from baseline in standing blood pressure after 4 weeks and 8 weeks []

3. Achieve blood pressure control target of < 140/90 mmHg after 8 weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	East Hanover	New Jersey	United States	07936
2		Investigative Centers		Germany

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00219193
• Other Study ID Numbers: CSPP100A2331
• First Posted: Sep 22, 2005
• Last Update Posted: Feb 7, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Novartis: Hypertension, aliskiren, blood pressure, valsartan, HCTZ
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Feb 7, 2017