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NCT01368536 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 975
- Enrollment target
NCT01368536: Clinical Trial Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01368536 is a Phase 4 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 975 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01368536, a Phase 4 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 975 participants
- Enrollment target
Study Summary
This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.
Primary Outcome
Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to
Interventions
- DRUG Chlorthalidone
- DRUG Amlodipine
- DRUG Placebo Capsule
- DRUG Valturna
- DRUG Placebo of Valturna Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 975 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
Why NCT01368536 stopped before completion
NCT01368536 is an interventional study that assigns participants to a tested intervention. The registered 975 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 5 interventions - of which Chlorthalidone is the first listed.
NCT01368536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01368536 about?
NCT01368536 is a clinical study titled "Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes". This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.
What is the current status of trial NCT01368536?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 975 participants. The study started on 2011-05. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01368536?
The interventions under investigation include: Chlorthalidone (DRUG), Amlodipine (DRUG), Placebo Capsule (DRUG), Valturna (DRUG), Placebo of Valturna Tablet (DRUG).
Who is sponsoring clinical trial NCT01368536?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01368536's enrollment target sits among peer trials
975 75th of 2000 higher than 1,926 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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