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Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aliskiren
Ramipril
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Aliskiren, Ramipril

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3
  • Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3
  • Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion Criteria:

  • Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).
  • History or evidence of a secondary form of hypertension.
  • History of transient ischemic cerebral attack within 12 months of visit 1.
  • Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
  • Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
  • Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Sites
  • Novartis Investigative Sites
  • Novartis Investigative Sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Aliskiren 300 mg

Aliskiren 150 mg

Aliskiren 75 mg

Ramipril 5 mg

Arm Description

Aliskiren 300 mg once daily

Aliskiren 150 mg once daily

Aliskiren 75 mg once daily

Ramipril 5 mg once daily

Outcomes

Primary Outcome Measures

Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint

Secondary Outcome Measures

Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint
To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.
Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg
To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.
Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP
To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.

Full Information

First Posted
September 12, 2007
Last Updated
February 28, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00529451
Brief Title
Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg
Official Title
An Eight Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing the Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg to Ramipril 5 mg in Patients With Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Aliskiren, Ramipril

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1613 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aliskiren 300 mg
Arm Type
Experimental
Arm Description
Aliskiren 300 mg once daily
Arm Title
Aliskiren 150 mg
Arm Type
Experimental
Arm Description
Aliskiren 150 mg once daily
Arm Title
Aliskiren 75 mg
Arm Type
Experimental
Arm Description
Aliskiren 75 mg once daily
Arm Title
Ramipril 5 mg
Arm Type
Active Comparator
Arm Description
Ramipril 5 mg once daily
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Intervention Description
Aliskiren
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Description
comparator
Primary Outcome Measure Information:
Title
Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Description
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Time Frame
Baseline and Week 8
Title
Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Description
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Time Frame
Baseline and Week 8
Title
Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Description
To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint
Description
To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.
Time Frame
Baseline and Week 8
Title
Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg
Description
To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.
Time Frame
Week 8
Title
Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP
Description
To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3 Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3 Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3 Exclusion Criteria: Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg). History or evidence of a secondary form of hypertension. History of transient ischemic cerebral attack within 12 months of visit 1. Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates) Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1. Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors. Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Sites
City
China
Country
China
Facility Name
Novartis Investigative Sites
City
India
Country
India
Facility Name
Novartis Investigative Sites
City
Thailand
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
33089502
Citation
Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
Results Reference
derived

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Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

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