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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

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

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

NCT ID

NCT00529451

First Posted

September 12, 2007

Last Updated

February 28, 2011

Sponsor

Novartis

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

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

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

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

Learn more about this trial

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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