Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00262236
• Collaborator: (none)
• Enrollment: 693
• Locations: 2
• Duration (Months): 9
• Patients Per Site: 346.5
• Patients Per Site Per Month: 38.6

Study Details

Study Description

Brief Summary

This is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 weeks.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 693 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Aug 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Outcome Measures

Primary Outcome Measures

1. Change from baseline in diastolic blood pressure after 12 weeks []

Secondary Outcome Measures

1. Change from baseline in systolic blood pressure after 12 weeks []

2. Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks []

3. Blood pressure of < 140/90 mmHg after 12 weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Outpatients 18 years of age and older.

2. Patients with essential hypertension.

Exclusion Criteria:

Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation,

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Investigative Centers		Germany
2	Novartis	Basel		Switzerland

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceutical, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00262236
• Other Study ID Numbers: CSPP100A2304
• First Posted: Dec 6, 2005
• Last Update Posted: Nov 18, 2016
• Last Verified: Nov 1, 2016

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

Study Results

No Results Posted as of Nov 18, 2016