Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal (ASSERTIVE)
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00865020
First received: March 17, 2009
Last updated: June 22, 2011
Last verified: June 2011
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Purpose
This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood Pressure Monitoring setting after a one week treatment withdrawal.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Aliskiren Drug: Telmisartan Drug: Placebo to Aliskiren Drug: Placebo to Telmisartan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Twelve-week, Randomized, Double-blind, Parallel Group Study to Evaluate the Prolonged Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg in Mild to Moderate Hypertensive Patients With the 24-hour Ambulatory Blood Pressure Measurement After 1 Week of Treatment Withdrawal Study Acronym: ASSERTIVE - AliSkiren Study of Profound antihypERtensive Efficacy in hyperTensIVE Patients |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period [ Time Frame: 12 weeks, 13 weeks ] [ Designated as safety issue: No ]An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.
Secondary Outcome Measures:
- Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period [ Time Frame: 12 weeks, 13 weeks ] [ Designated as safety issue: No ]An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.
- Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period [ Time Frame: Baseline, 13 weeks ] [ Designated as safety issue: No ]An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate.
- Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period [ Time Frame: Baseline, 12 weeks, 13 weeks ] [ Designated as safety issue: No ]
Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis.
The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate.
The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.
- Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period [ Time Frame: Baseline, 12 weeks, 13 weeks ] [ Designated as safety issue: No ]
Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis.
The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate.
The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors.
| Enrollment: | 822 |
| Study Start Date: | March 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aliskiren 300 mg
Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
|
Drug: Aliskiren
Aliskiren 150 mg tablets taken orally daily. 1 tablet for the first two weeks followed by 2 tablets for 10 weeks.
Drug: Placebo to Aliskiren
Placebo to Aliskiren tablets taken orally daily. 1 Tablet for the first 2 weeks and 2 tablets during the no treatment (withdrawal) week.
|
|
Active Comparator: Telmisartan 80 mg
Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
|
Drug: Telmisartan
Telmisartan 40 mg capsules taken orally daily. 1 capsule the first 2 weeks followed by 2 capsules for 10 weeks.
Drug: Placebo to Telmisartan
Placebo to Telmisartan capsule taken orally daily. 1 capsule for the first 2 weeks and 2 capsules during the no treatment (withdrawal) week.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg
- 24-hr mean ambulatory systolic blood pressure ≥ 135 mmHg
Exclusion Criteria:
- Severe hypertension defined as mean sitting systolic blood pressure ≥ 180 mmHg and/or mean sitting diastolic blood pressure ≥ 110 mmHg
- Patients with Type 1 diabetes mellitus
- Secondary hypertension of any etiology
- Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865020
Locations
| Brazil | |
| Investigative Site | |
| Sorocaba, Brazil | |
| Canada | |
| Investigative Site | |
| Gatineau, Canada | |
| Ecuador | |
| Investigative Site | |
| Guayaquil, Ecuador | |
| Germany | |
| Investigative Site | |
| Erfurt, Germany | |
| Hungary | |
| Invesitagtive Site | |
| Budapest, Hungary | |
| Korea, Republic of | |
| Investigative Site | |
| Cheongju, Korea, Republic of | |
| Malaysia | |
| Investigative Site | |
| Kuala Lumpur, Malaysia | |
| Mexico | |
| Investigative Site | |
| Mexico City, Mexico | |
| Panama | |
| Investigative Site | |
| Panama City, Panama | |
| Philippines | |
| Investigative Site | |
| Manila, Philippines | |
| Singapore | |
| Investigative Site | |
| Singapore, Singapore | |
| Slovakia | |
| Investigative Site | |
| Bratislava, Slovakia | |
| Spain | |
| Investigative Site | |
| Sevilla, Spain | |
| Turkey | |
| Investigative Site | |
| Istanbul, Turkey | |
| United Kingdom | |
| Investigative Site | |
| Westbury, United Kingdom | |
| Venezuela | |
| Investigative Site | |
| Caracas, Venezuela | |
Sponsors and Collaborators
Novartis
Investigators
| Study Chair: | Novartis | Novartis |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00865020 History of Changes |
| Other Study ID Numbers: | CSPP100A2408 |
| Study First Received: | March 17, 2009 |
| Results First Received: | June 22, 2011 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Brazil: Ministry of Health Canada: Health Canada Ecuador: Public Health Ministry Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Korea: Food and Drug Administration Malaysia: Ministry of Health Mexico: Ministry of Health Panama: Ministry of Health Philippines: Bureau of Food and Drugs Singapore: Health Sciences Authority Slovakia: State Institute for Drug Control Spain: Spanish Agency of Medicines Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency Venezuela: Ministry of Health and Social Development |
Keywords provided by Novartis:
|
Hypertension ABPM systolic blood pressure diastolic blood pressure |
cardiovascular disease aliskiren telmisartan |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Antihypertensive Agents Telmisartan Benzoates Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013