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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00219076
• Collaborator: (none)
• Enrollment: 504
• Locations: 2
• Patients Per Site: 252

Study Details

Study Description

Brief Summary

To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Six-week, Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren 150 mg and Amlodipine 5 mg Compared to Amlodipine 5 mg and 10 mg in Hypertensive Patients Not Adequately Responsive to Amlodipine 5 mg
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Oct 1, 2005

Outcome Measures

Primary Outcome Measures

1. Change from baseline in mean sitting diastolic blood pressure after 6 weeks []

Secondary Outcome Measures

1. Change from baseline in mean sitting systolic blood pressure after 6 weeks []

2. Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks []

3. Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks []

4. Change from baseline in standing diastolic blood pressure after 6 weeks []

5. Change from baseline in standing systolic blood pressure after 6 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

• 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
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.

• ClinicalTrials.gov Identifier: NCT00219076
• Other Study ID Numbers: CSPP100A2305
• First Posted: Sep 22, 2005
• Last Update Posted: May 18, 2017
• Last Verified: May 1, 2017

• Keywords provided by , ,: Hypertension, aliskiren, blood pressure, amlodipine
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of May 18, 2017