A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00219063
• Collaborator: (none)
• Enrollment: 844
• Location: 1
• Duration (Months): 12.9
• Patients Per Site Per Month: 65.4

Study Details

Study Description

Brief Summary

To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 844 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A 26 Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing Aliskiren to Ramipril With Optional Addition of Hydrochlorothiazide, Followed by a 4 Week Double-blind, Randomized, Placebo-controlled Withdrawal in Patients With Essential Hypertension
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Outcome Measures

Primary Outcome Measures

1. Change from baseline in diastolic blood pressure after 26 weeks []

Secondary Outcome Measures

1. Change from baseline in systolic blood pressure after 26 weeks []

2. Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks []

3. Change from baseline in systolic blood pressure after 6 weeks and 12 weeks []

4. Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 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 inclusion exclusion criteria also apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	East Hanover	New Jersey	United States

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: NCT00219063
• Other Study ID Numbers: CSPP100A2306
• First Posted: Sep 22, 2005
• Last Update Posted: May 17, 2017
• Last Verified: May 1, 2017

• Keywords provided by Novartis: Hypertension, aliskiren, blood pressure, Ramipril, hydrochlorothiazide
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of May 17, 2017