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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00219180
• Collaborator: (none)
• Enrollment: 1,797
• Locations: 2
• Duration (Months): 15
• Patients Per Site: 898.5
• Patients Per Site Per Month: 59.8

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 1797 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Sep 1, 2006
• Actual Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Change from baseline in systolic blood pressure after week 8 []

2. Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 and 8 weeks []

3. Blood pressure control target of < 140/90 mmHg after 4 and 8 weeks []

4. Evaluate 24-hour ambulatory blood pressure monitoring in a subset of patients []

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

• History of Hypertensive encephalopathy or cerebrovascular accident

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: NCT00219180
• Other Study ID Numbers: CSPP100A2327
• First Posted: Sep 22, 2005
• Last Update Posted: May 17, 2017
• Last Verified: May 1, 2017

• Keywords provided by Novartis: Hypertension, Aliskiren
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of May 17, 2017