A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension

This study has been completed.

Study NCT00631917 Information provided by Novartis

First Received on March 3, 2008. Last Updated on June 30, 2011 History of Changes

Results First Received: January 5, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Aliskiren Drug: Ramipril Other: Placebo to Ramipril Other: Placebo to Aliskiren

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Aliskiren	For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
Ramipril	For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.

Participant Flow: Overall Study

	Aliskiren	Ramipril
STARTED	375	399
COMPLETED	287	291
NOT COMPLETED	88	108
Adverse Event	34	45
Abnormal laboratory value(s)	2	1
Abnormal test procedure result(s)	3	2
Unsatisfactory therapeutic effect	8	14
No longer required study drug	0	1
Protocol deviation	6	5
Subject withdrew consent	25	33
Lost to Follow-up	7	7
Administrative problems	2	0
Death	1	0

Baseline Characteristics

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Reporting Groups

	Description
Aliskiren	For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
Ramipril	For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.

Baseline Measures

	Aliskiren	Ramipril	Total
Number of Participants [units: participants]	375	399	774
Age [units: years] Mean ± Standard Deviation	59.3 ± 6.99	59.3 ± 6.65	59.3 ± 6.81
Age, Customized [units: Participants]
< 65 years	299	313	612
65 years and greater	76	86	162
Gender [units: participants]
Female	194	194	388
Male	181	205	386

Outcome Measures

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1. Primary:

Percentage of Participants With Colonic Pathology [ Time Frame: 54 weeks ]

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2. Primary:

Summary of the End of Study Colonoscopy Results [ Time Frame: 54 weeks ]

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3. Secondary:

Percentage of Participants With Each of the Individual Components of Colonic Pathology [ Time Frame: 54 weeks ]

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4. Secondary:

Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment [ Time Frame: 54 weeks ]

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5. Secondary:

Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target [ Time Frame: Weeks 8, 30 and End of Study (54 weeks) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00631917 History of Changes
Other Study ID Numbers:	CSPP100A2404
Study First Received:	March 3, 2008
Results First Received:	January 5, 2011
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration