Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00219024
• Collaborator: (none)
• Enrollment: 2,775
• Locations: 2
• Duration (Months): 10
• Patients Per Site: 1387.5
• Patients Per Site Per Month: 138.9

Study Details

Study Description

Brief Summary

To demonstrate the efficacy and safety of aliskiren given to patients with essential hypertension, at doses of 75 mg, 150 mg and 300 mg alone, and in combination with hydrochlorothiazide (HCTZ)

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 2775 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: An 8 Week Double-blind, Multicenter, Randomized, Multifactorial, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Jun 1, 2005

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 blood pressure after 8 weeks []

2. Diastolic blood pressure is < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks []

3. Blood pressure < 140/90 mmHg []

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

5. Change from baseline in standing systolic blood pressure 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

• 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.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00219024
• Other Study ID Numbers: CSPP100A2204
• First Posted: Sep 22, 2005
• Last Update Posted: May 17, 2017
• Last Verified: May 1, 2017

• Keywords provided by Novartis: Hypertension, aliskiren, blood pressure, hydrochlorothiazide (HCTZ).
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of May 17, 2017