A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00219089
• Collaborator: (none)
• Enrollment: 839
• Locations: 2
• Duration (Months): 9
• Patients Per Site: 419.5
• Patients Per Site Per Month: 46.8

Study Details

Study Description

Brief Summary

To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 839 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: An Eight-week, Randomized, Double-blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Aug 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Change from baseline to week 4 endpoint in mean sitting diastolic blood pressure []

2. Change from baseline to week 8 endpoint in mean sitting systolic blood pressure []

3. Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline 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 with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.

• 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: NCT00219089
• Other Study ID Numbers: CSPP100A2307
• First Posted: Sep 22, 2005
• Last Update Posted: May 17, 2017
• Last Verified: May 1, 2017

• Keywords provided by Novartis: Hypertension, aliskiren, blood pressure, diabetes mellitus, ramipril
• Additional relevant MeSH terms: Hypertension; Diabetes Mellitus

Study Results

No Results Posted as of May 17, 2017