Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
Public ClinicalTrials.gov record NCT01788358. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter, Open-Label, Long-Term Safety and Efficacy Study of the Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Adult Subjects With Moderate to Severe Essential Hypertension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension. Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total). Subjects who do not tolerate an increased dose will be treated at their highest tolerable dose.
Study identification
- NCT ID
- NCT01788358
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 508 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2013 (Actual)
- Primary completion
- May 1, 2014 (Actual)
- Completion
- May 1, 2014 (Actual)
- Last update posted
- Oct 24, 2017
2013 – 2014
United States locations
- U.S. sites
- 39
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Foley | Alabama | 36535 | — |
| Not listed | Carmichael | California | 95608 | — |
| Not listed | Los Angeles | California | 90057 | — |
| Not listed | Spring Valley | California | 91978 | — |
| Not listed | Milford | Connecticut | 06460 | — |
| Not listed | Coral Gables | Florida | 33114-4192 | — |
| Not listed | Hallandale | Florida | 33009 | — |
| Not listed | Hollywood | Florida | 33083 | — |
| Not listed | Jacksonville | Florida | 32216 | — |
| Not listed | Jupiter | Florida | 33458 | — |
| Not listed | Tampa | Florida | 33606 | — |
| Not listed | Atlanta | Georgia | 30338 | — |
| Not listed | Valparaiso | Indiana | 46383 | — |
| Not listed | Newton | Kansas | 67114 | — |
| Not listed | Wichita | Kansas | 67205 | — |
| Not listed | Lexington | Kentucky | 40504 | — |
| Not listed | New Orleans | Louisiana | 70119 | — |
| Not listed | Auburn | Maine | 04240 | — |
| Not listed | Elkridge | Maryland | 21075 | — |
| Not listed | Brockton | Massachusetts | 02301 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Shelby | North Carolina | 28150 | — |
| Not listed | Cincinnati | Ohio | 45224 | — |
| Not listed | Cincinnati | Ohio | 45245 | — |
| Not listed | Cincinnati | Ohio | 45246 | — |
| Not listed | Columbus | Ohio | 43213 | — |
| Not listed | Greenville | South Carolina | 29615 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Rapid City | South Dakota | 57702 | — |
| Not listed | Nashville | Tennessee | 37203 | — |
| Not listed | New Tazewell | Tennessee | 37825 | — |
| Not listed | Beaumont | Texas | 77701 | — |
| Not listed | Bryan | Texas | 77802 | — |
| Not listed | Carrollton | Texas | 75010 | — |
| Not listed | Dallas | Texas | 75230 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | Kenosha | Wisconsin | 53142 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01788358, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 24, 2017 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01788358 live on ClinicalTrials.gov.